Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK3915393 Capsules
GSK3915393 · 2 trials · 3 indications
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcome; or is a suspected transmission of any infectious agent via an authorized medicinal product.
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Number of participants with clinically significant changes in Vital signs (temperature, systolic and diastolic blood pressure \[BP\], pulse rate and respiratory rate \[RR\]) will be assessed.
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs were presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs are presented.
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase \[ALT\]), \>=2\*ULN (U/L) (Aspartate Aminotransferase (\[AST\]), \>=2\*ULN (Alkaline Phosphatase \[ALP\]) (U/L), \>=1.5\*ULN (micromoles per liter) (bilirubin), \<2 or \>2.75 millimoles/liter (L) (mmol/L)(calcium), \<3 or \>11 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), \<130 or \>150 mmol/L (sodium),\<50 or \>85 grams/liter (protein). Participants were counted in worst case category that their value changes to (low, within \[w/in\] range or no change \[NC\], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%).
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as within (w/in) range.
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (within \[w/in\] range or no change \[NC\], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category.
Blood samples were collected for analysis of hematology parameters. PCI ranges were \>1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' \& 'To High', so the percentages may not add to 100%.
Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR), body temperature, respiratory rate (RR) and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (millimeters of mercury\[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute):\<=8 (low) or \>20 (high) and body temperature (degrees Celsius) \<=35.5 (low) or \>38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%.
Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*ULN (U/L)(ALT), \>=2\*ULN (U/L) (AST), \>=2\*ULN (ALP) (U/L), \>=1.5\*ULN (micromoles per liter) (bilirubin), \<2 or \>2.75 millimoles/liter (L) (mmol/L)(calcium), \<3 or \>11 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), \<130 or \>150 mmol/L (sodium),\<50 or \>85 grams/liter (protein). Participants were counted in worst case category that their value changes to (low, within \[w/in\] range or no change \[NC\], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%).
Blood samples were collected for analysis of chemistry parameters. PCI range for Urea: High \>10.5 mmol/L. Participants were counted in worst case category that their value changes to (within \[w/in\] range or NC, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category.
Blood samples were collected for analysis of creatinine. Participants were counted under increase of PCI if they had change from Baseline \> 44.2 micromoles per Liter for any post Baseline assessment. Participants who did not meet this PCI criteria are counted as w/in range. Participants whose laboratory value became within range, were recorded in 'To within Range' category.
Blood samples were collected for analysis of hematology parameters. PCI ranges were 1\*10\^9 cell per liter (cells/L) (eosinophils), \<0.2 or \>0.54 proportion of red blood cells in blood (hematocrit), \<80 or \>180 grams per liter(g/L) (hemoglobin), \<3 or \>20 x10\^9 cells/L (leukocytes), \<0.8\*10\^9 cells/L (lymphocytes), \<1.5 or \>16\*10\^9 cells/L (neutrophils) and \<100 or \>550\*10\^9 cells/L (platelets). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' \& 'To High', so the percentages may not add to 100%.
Vital signs included DBP, SBP, PR, body temperature, RR and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (mmHg): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute):\<=8 (low) or \>20 (high) and body temperature (degrees Celsius) \<=35.5 (low) or \>38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%.
Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
A full physical examination was performed which included, at a minimum, assessments of the Skin, Cardiovascular, Respiratory, Gastrointestinal and Neurological systems.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Cmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. Tmax was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. AUC(0-inf) was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393.
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3915393. For Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, concentrations after 24 hours post-dose were expected to be non-quantifiable. t1/2 was derived based on collected assessments (up to 24 hours for Part C: GSK3915393 20 mg+ Water and Part C: GSK3915393 20 mg+ GFJ, up to 60 hours for Part C: GSK3915393 20 mg+ ITZ). Only the quantifiable concentration time points were to be considered for assessment of pharmacokinetic parameters.
| Arm | Type | Description |
|---|---|---|
| Part A: GSK3915393 | EXPERIMENTAL | Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition. |
| Part B: Nintedanib followed by Nintedanib plus GSK3915393 | EXPERIMENTAL | Male participants will be randomized to receive Nintedanib in Period 1 followed by co-administration of Nintedanib and GSK3915393 in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
| Part B: Nintedanib plus GSK3915393 followed by Nintedanib | EXPERIMENTAL | Male participants will be randomized to receive co-administration of Nintedanib and GSK3915393 in Period 1 followed by Nintedanib in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
| Part A:GSK3915393 DLs 1,3,4,intravenous (IV) microdose and placebo (Sequence A) | EXPERIMENTAL | In Part A, participants will receive dose levels (DLs) 1, 3, 4, IV microdose of GSK3915393, and placebo in a pre-determined sequence (Sequence A). There will be a washout period of at least 7 days between each dose. Oral dose levels will be determined based on safety, tolerability and PK data. |
| Part A:GSK3915393 DLs 1,2,4,IV microdose and placebo (Sequence B) | EXPERIMENTAL | In Part A, participants will receive dose levels 1, 2, 4, IV microdose of GSK3915393 and placebo in a pre-determined sequence (Sequence B). There will be a washout period of at least 7 days between each dose. Oral dose levels will be determined based on safety, tolerability and PK data. |
| Part A:GSK3915393 DLs 1,2,3,IV microdose and placebo (Sequence C) | EXPERIMENTAL | In Part A, participants will receive dose levels 1, 2, 3, IV microdose of GSK3915393 and placebo in a pre-determined sequence (Sequence C). There will be a washout period of at least 7 days between each dose. Oral dose levels will be determined based on safety, tolerability and PK data. |
| Part A:GSK3915393 DLs 2,3,4,IV microdose and placebo (Sequence D) | EXPERIMENTAL | In Part A, participants will receive dose levels 2, 3, 4, IV microdose of GSK3915393 and placebo in a pre-determined sequence (Sequence D). There will be a washout period of at least 7 days between each dose. Oral dose levels will be determined based on safety, tolerability and PK data. |
| Part B: Cohort 1: Participants receiving GSK3915393 DL X | EXPERIMENTAL | Participants will receive GSK3915393 dose level X twice daily during Part B of the study. Dose levels will be determined based on safety, tolerability and PK data from Part A. |
| Part B: Cohort 1: Participants receiving placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching GSK3915393 dose level X during Part B of the study. |
| Part B: Cohort 2: Participants receiving GSK3915393 DL Y | EXPERIMENTAL | Participants will receive GSK3915393 dose level Y twice daily during Part B of the study. Dose levels will be determined based on safety, tolerability and PK data from Part A and Part B. |
| Part B: Cohort 2: Participants receiving placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching GSK3915393 dose level Y twice daily during Part B of the study |
| Part B: Cohort 3: Participants receiving GSK3915393 DL Z | EXPERIMENTAL | Participants will receive GSK3915393 dose level Z twice daily during Part B of the study. Dose levels will be determined based on safety, tolerability and PK data from Part A and Part B. |
| Part B: Cohort 3: Participants receiving placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching GSK3915393 dose level Z twice daily during Part B of the study. |
| Part C: GSK3915393 IV/GSK3915393 IV+ITZ/GSK3915393+water/GSK3915393+GFJ/GSK3915393+ITZ (Sequence A) | EXPERIMENTAL | Participants will receive GSK3915393 IV microdose in period 1 followed by combination of GSK3915393 IV microdose and itraconazole (ITZ) in period 2. Participants will then receive oral GSK3915393 plus water in period 3, oral GSK3915393 plus grape fruit juice (GFJ) in period 4 and oral GSK3915393 plus ITZ in period 5. |
| Part C: GSK3915393 IV/GSK3915393 IV+ITZ/GSK3915393+GFJ/GSK3915393+water/GSK3915393+ITZ (Sequence B) | EXPERIMENTAL | Participants will receive GSK3915393 IV microdose in period 1 followed by combination of GSK3915393 IV microdose and ITZ in period 2. Participants will then receive oral GSK3915393 plus GFJ in period 3, oral GSK3915393 plus water in period 4 and oral GSK3915393 plus ITZ in period 5. |
| Name | Type | Description |
|---|---|---|
| Part A: Placebo | DRUG | Placebo will be administered. |
| Nintedanib | DRUG | Nintedanib will be administered. |
| GSK3915393 | DRUG | GSK3915393 will be administered. |
| GSK3915393 Capsules | DRUG | GSK3915393 capsules will be given orally. |
| GSK3915393 Solution for Infusion | DRUG | GSK3915393 solution for infusion will be administered intravenously. |
| Placebo capsules | DRUG | Placebo matching GSK3915393 capsules will be given orally. |
| Itraconazole | DRUG | Participants will be administered with GSK3915393 along with ITZ orally |
| Water | OTHER | Participants will be administered with GSK3915393 along with water orally |
| Grape fruit juice | OTHER | Participants will be administered with GSK3915393 along with GFJ orally |
Inclusion Criteria: For Part A and Part B: Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessments, and laboratory tests Body weight at least 50.0 kilograms (kg) (110 pound...
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GSK3915393 is an investigational small molecule developed by GSK plc. It has been studied in Phase 1 clinical trials involving healthy participants, with research focused on celiac disease and idiopathic pulmonary fibrosis. It is not an approved medicine and remains in early clinical development.
GSK3915393 has been evaluated in clinical studies related to celiac disease and idiopathic pulmonary fibrosis. The trials conducted to date enrolled healthy volunteers rather than patients, so the drug has no approved use. Its development remains at the Phase 1 stage.
GSK3915393 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 studies of the compound in the United States and the United Kingdom.
GSK3915393 is in Phase 1 development. Two Phase 1 trials have been completed, and no later-stage trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator for any indication.
GSK3915393 has been studied in two completed Phase 1 trials. NCT04604795 evaluated safety, tolerability, and pharmacokinetics in healthy participants and drug interactions with grapefruit juice and itraconazole in the United Kingdom. NCT06625489 assessed safety, tolerability, and blood levels in healthy participants of Chinese, Japanese, and European ancestry in the United States.
Yes. GSK3915393 Capsules is an alternative name for GSK3915393, referring to the oral capsule formulation used in its clinical studies. Both names describe the same investigational small molecule developed by GSK plc.