Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3179106 · 2 trials · 1 indication
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Physical examination will include the assessment of the cardiovascular, respiratory, gastrointestinal and neurological systems. A brief physical examination will be conducted at follow-up visit which include, at a minimum assessments of the lungs, cardiovascular system, and abdomen (liver and spleen). Height and weight will also be measured and recorded (height will only be recorded at screening assessment).
Triplicate 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval (QTc).
Three readings of systolic and diastolic pressure will be taken at each time point and the average will be calculated electronically
Temperature measurements will be taken at Screening, Day-1 and pre-dose in each treatment period. For all other vital sign time points if clinically indicated
Three readings of systolic and diastolic pressure will be taken at each time point and the average will be calculated electronically
Clinical safety laboratory assessments include hematology, clinical chemistry, urinalysis and additional parameters
The Bristol Stool Form Scale describes 7 types of stool and will be used by the subject to monitor the changes in defecation pattern during the study
| Arm | Type | Description |
|---|---|---|
| 10 mg of GSK3179106 QD-Cohort 1 | EXPERIMENTAL | Eligible six subjects will receive 10 mg oral dose once daily for 14 days |
| 50 mg of GSK3179106 QD-Cohort 2 | EXPERIMENTAL | Eligible six subjects will receive 50 mg oral dose once daily for 14 days |
| 200 mg of GSK3179106 QD-Cohort 3 | EXPERIMENTAL | Eligible six subjects will receive 200 mg oral dose once daily for 14 days |
| 400 mg of GSK3179106 QD-Cohort 4 | EXPERIMENTAL | Eligible six subjects will receive 400 mg oral dose once daily for 14 days |
| 25 mg of GSK3179106 BID-Cohort 5 | EXPERIMENTAL | Eligible six subjects will receive 25 mg oral dose twice daily for 14 days |
| 200 mg of GSK3179106 BID-Cohort 6 | EXPERIMENTAL | Eligible six subjects will receive 200 mg oral dose twice daily for 14 days |
| Matching placebo QD-Cohort 1, 2, 3, 4 | PLACEBO_COMPARATOR | Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days |
| Matching placebo BID-Cohort 5, 6 | PLACEBO_COMPARATOR | Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days |
| Cohort 1 | EXPERIMENTAL | Subjects will receive 1 placebo and 3 escalating doses in one of the four treatment periods. The planned dose range is 10 mg to 200 mg. A review of safety and tolerability will occur prior to administration of the next dose level and the same procedure will be followed for each escalating dosing period. The actual doses to be administered may be adjusted based on safety, tolerability, and pharmacokinetic data at previous dose levels; these dose adjustments may involve either an increase or a decrease in the planned dose for both Cohorts 1 and 2 |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will proceed after completion of the treatment periods in Cohort 1. Subjects assigned to Cohort 2 will participate in up to 4 dosing periods which include up to 2 escalating doses and placebo in Periods 1 and 2, and a pilot food effect in Periods 3 and 4. A review of safety and tolerability will occur prior to administration of the next dose level and the same procedure will be followed for each escalating dosing period. The actual doses to be administered may be adjusted based on safety, tolerability, and pharmacokinetic data at previous dose levels; these dose adjustments may involve either an increase or a decrease in the planned dose for both Cohorts 1 and 2 |
| Name | Type | Description |
|---|---|---|
| GSK3179106 | DRUG | It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally |
| Matched Placebo | DRUG | It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally |
| Placebo | DRUG | Placebo will be provided as white to slightly colored round or oblong tablet for oral administration with unit dose strength to match actives across all strengths |
Inclusion Criteria: * Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel h...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 3 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | - | Undisclosed |
| Johnson & Johnson | JNJ | 1 | - | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | N/A | Undisclosed |
GSK3179106 is an investigational small molecule being developed by GSK plc for the treatment of Irritable Bowel Syndrome (IBS). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and tolerability in early-stage trials.
The specific molecular target of GSK3179106 has not been disclosed in the available clinical trial information. The drug is being studied for its effects on gastrointestinal transit time and pharmacodynamic biomarkers in healthy volunteers, but its precise mechanism of action is not publicly detailed.
GSK3179106 is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy volunteers with Irritable Bowel Syndrome.
GSK3179106 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not received FDA approval or any other regulatory approval for the treatment of Irritable Bowel Syndrome.
GSK3179106 has been studied in two completed Phase 1 clinical trials. The first, NCT02727283, was a single ascending dose study in 16 healthy volunteers. The second, NCT02798991, was a repeat dose escalation study in 46 healthy subjects, evaluating safety, tolerability, pharmacokinetics, gastrointestinal transit time, and biomarkers. Both trials were conducted in Australia.
No alternative names for GSK3179106 have been reported in the clinical trial records. The drug is identified solely by its compound code GSK3179106 in the available information, and no other brand names or aliases are associated with it.