Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Camlipixant
GSK5464714- Camlipixant · 11 trials · 6 indications
Assessed using an ambulatory cough monitor
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: 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 in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.
Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Assessed by Worst Itch Numeric Rating Scale \[WI-NRS\] The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
Assessed using an ambulatory cough monitor
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose
| Arm | Type | Description |
|---|---|---|
| BLU-5937 25 mg | EXPERIMENTAL | BLU-5937 oral dose 25 mg twice a day. |
| BLU-5937 50 mg | EXPERIMENTAL | BLU-5937 oral dose 50 mg twice a day. |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo for BLU-5937 oral dose twice a day. |
| Placebo/Placebo or Camlipixant | PLACEBO_COMPARATOR | Participants will receive placebo in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 1/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 2/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 3/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B |
| BLU-5937 oral tablet | EXPERIMENTAL | Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks. |
| Placebo oral tablet | PLACEBO_COMPARATOR | Eligible participants will receive matching Placebo BID orally for 4 weeks. |
| BLU-5937 Dose A | EXPERIMENTAL | BLU-5937 oral dose A twice a day. |
| BLU-5937 Dose B | EXPERIMENTAL | BLU-5937 oral dose B twice a day. |
| BLU-5937 Dose C | EXPERIMENTAL | BLU-5937 oral dose C twice a day. |
| BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour) | EXPERIMENTAL | BLU-5937 oral dose A twice a day. |
| Placebo (Population with baseline cough < 25 coughs/hour) | PLACEBO_COMPARATOR | Matching Placebo for BLU-5937 oral dose twice a day. |
| Sequence 1 | EXPERIMENTAL | In sequence 1, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 under fasting condition (Treatment A), followed by single dose of GSK5464714 in fed condition (Treatment B). There will be a washout period of minimum 7 days between each period. |
| Sequence 2 | EXPERIMENTAL | In sequence 2, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 in fed condition (Treatment B), followed by single dose of GSK5464714 under fasting condition (Treatment A). There will be a washout period of minimum 7 days between each period. |
| Part 1: Moderate HI Participants | EXPERIMENTAL | Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state. |
| Part 1: Matched Healthy Participants to Moderate HI | EXPERIMENTAL | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 2: Severe HI Participants | EXPERIMENTAL | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 2: Matched Healthy Participants to Severe HI | EXPERIMENTAL | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | EXPERIMENTAL | Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5. |
| Part 2: Dabigatran etexilate 150 mg + camlipixant 50 mg | EXPERIMENTAL | Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5. |
| Part 1: Camlipixant 50 mg + Rifampin 600 mg | EXPERIMENTAL | Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. |
| Part 2: Camlipixant 50 mg + Rabeprazole 20 mg | EXPERIMENTAL | Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4 |
| Single Ascending Doses | EXPERIMENTAL | Single ascending doses, 6 dose levels |
| Multiple Ascending Doses | EXPERIMENTAL | Multiple ascending doses, 3 dose levels |
| Name | Type | Description |
|---|---|---|
| BLU-5937 | DRUG | Oral administration of BLU-5937 Tablets. |
| Placebo | DRUG | Oral administration of matching placebo for BLU-5937 Tablets. |
| Camlipixant | DRUG | Camlipixant to be administered |
| GSK5464714- Camlipixant | DRUG | GSK5464714- Camlipixant will be administered |
| Dabigatran etexilate | DRUG | Dabigatran etexilate will be administered |
| Gemfibrozil | DRUG | Gemfibrozil will be administered. |
| Rabeprazole | DRUG | Rabeprazole will be administered |
| Rifampin | DRUG | Rifampin will be administered. |
Inclusion Criteria: * Capable of giving signed informed consent * Refractory chronic cough (including unexplained chronic cough) for at least one year * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
GSK5464714-Camlipixant is an investigational small molecule being developed for the treatment of cough. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in healthy participants to evaluate its effects, with a focus on respiratory conditions.
GSK5464714-Camlipixant is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
GSK5464714-Camlipixant is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage trials to assess its safety, tolerability, and how it is processed by the body.
GSK5464714-Camlipixant has one completed Phase 1 clinical trial registered under NCT06497517. This study, titled 'A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants,' enrolled 14 participants in the United States and evaluated the drug's concentrations after food intake.
Yes, GSK5464714-Camlipixant is also known as Camlipixant. The drug is referred to by both names in clinical and research contexts. It is a small molecule being developed for cough and is currently in Phase 1 clinical trials.