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GSK3179106

Phase 1

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 8, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02798991A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal SubjectsPHASE1 COMPLETED 46 — — Jun 1, 2016Nov 1, 2016Jan 18, 20171 Australia
NCT02727283A Phase 1, Randomized, Placebo-Controlled, Ascending Cohort, Dose Escalation Study in Normal Healthy VolunteersPHASE1 COMPLETED 16 — — Nov 26, 2015Mar 18, 2016May 8, 20171 Australia
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Study Endpoints
Primary Endpoints
Number of subjects with adverse event (AE)
Up to Day 25

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

Number of subjects with adverse events (AE) and clinical observations as a measure of safety
Up to 10 weeks in each cohort

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.

Assessment of physical examination findings as a measure of safety
Screening, Day-1 and at follow-up (up to 10 weeks) in each cohort

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).

Safety as assessed by 12-lead electrocardiogram (ECG)
Up to 10 weeks in each cohort

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).

Safety as assessed by systolic and diastolic blood pressure measurements
Up to 10 weeks in each cohort

Three readings of systolic and diastolic pressure will be taken at each time point and the average will be calculated electronically

Safety as assessed by temperature measurements
Up to 10 weeks in each cohort

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

Safety as assessed by pulse rate measurements
Up to 10 weeks in each cohort

Three readings of systolic and diastolic pressure will be taken at each time point and the average will be calculated electronically

Composite of clinical laboratory assessments as a measure of safety includes hematology, clinical chemistry and urinalysis
Up to 10 weeks in each cohort

Clinical safety laboratory assessments include hematology, clinical chemistry, urinalysis and additional parameters

Bristol Stool Form Scale
Up to Day 4 in each cohort

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

Secondary Endpoints
Area under the plasma concentration-time curve (AUC) from zero to time t (AUC [0-t]) of GSK3179106 administered under fasting condition
Day 1 Pre-dose and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 18 h, 24 h, 36 h, 48 h, 60 h and 72 h postdose in each treatment period of cohort 1
AUC from zero to infinity (AUC [0-infinity]) of GSK3179106 administered under fasting condition
Day 1 Pre-dose and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 18 h, 24 h, 36 h, 48 h, 60 h and 72 h post-dose in each treatment period of cohort 1
AUC from zero to 24 h (AUC [0-24 h]) of GSK3179106 administered under fasting condition
Day 1 Pre-dose and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 18 h, 24 h, 36 h, 48 h, 60 h and 72 h post-dose in each treatment period of cohort 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
10 mg of GSK3179106 QD-Cohort 1EXPERIMENTALEligible six subjects will receive 10 mg oral dose once daily for 14 days
50 mg of GSK3179106 QD-Cohort 2EXPERIMENTALEligible six subjects will receive 50 mg oral dose once daily for 14 days
200 mg of GSK3179106 QD-Cohort 3EXPERIMENTALEligible six subjects will receive 200 mg oral dose once daily for 14 days
400 mg of GSK3179106 QD-Cohort 4EXPERIMENTALEligible six subjects will receive 400 mg oral dose once daily for 14 days
25 mg of GSK3179106 BID-Cohort 5EXPERIMENTALEligible six subjects will receive 25 mg oral dose twice daily for 14 days
200 mg of GSK3179106 BID-Cohort 6EXPERIMENTALEligible six subjects will receive 200 mg oral dose twice daily for 14 days
Matching placebo QD-Cohort 1, 2, 3, 4PLACEBO_COMPARATOREligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days
Matching placebo BID-Cohort 5, 6PLACEBO_COMPARATOREligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days
Cohort 1EXPERIMENTALSubjects 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 2EXPERIMENTALCohort 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
Interventions
NameTypeDescription
GSK3179106DRUGIt 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 PlaceboDRUGIt 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
PlaceboDRUGPlacebo 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
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Australia
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Competitive Landscape -Irritable Bowel Syndrome 13 trials
CompanyTickerTrialsLead PhaseDrugs
Ardelyx, Inc.ARDX4PHASE3Tenapanor
AbbVie, Inc.ABBV2PHASE3Eluxadoline
Disc Medicine, Inc.IRON1PHASE2DISC-0974
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2 — Undisclosed
Johnson & JohnsonJNJ1 — Anti TNF therapy including infliximab, No Biologics
Cooper Companies, Inc.COO1NAUndisclosed
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