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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03154086




Registration number
NCT03154086
Ethics application status
Date submitted
12/05/2017
Date registered
15/05/2017

Titles & IDs
Public title
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
Scientific title
A Phase I, First Time in Human, Two Part, Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblind), Single and Repeat Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
Secondary ID [1] 0 0
207440
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK3352589
Treatment: Drugs - Matching Placebo

Experimental: Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg - Subjects will receive single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 1:GSK3352589 2mg/ Placebo/GSK3352589 15mg/50mg - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 1: GSK3352589 2mg/5mg/Placebo/GSK3352589 50mg - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 1: GSK3352589 2mg/5mg/15mg/Placebo - Subjects will receive single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 2: GSK3352589 25mg Fasted/GSK3352589 25mg Fed - Subjects will receive single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and Period 2 (fed state). Subjects will return for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A: Cohort 2: Placebo Fasted/Placebo Fed - Subjects will receive single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and Period 2 (fed state). Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 3: GSK3352589 150 mg/Placebo - Subjects will receive single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 3: Placebo/GSK3352589 400 mg - Subjects will receive single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part A:Cohort 3: GSK3352589 150mg/GSK3352589 400mg - Subjects will receive single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Subjects will return for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.

Experimental: Part B: GSK3352589 - Subjects will receive repeat oral doses of GSK3352589 of 5 mg, 15 mg, 50 mg, 100 mg or 200 mg twice daily administered for 14 days.

Placebo comparator: Part B: Placebo - Subjects will receive repeat oral doses of placebo twice a day tablet administered for 14 days.


Treatment: Drugs: GSK3352589
It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.

Treatment: Drugs: Matching Placebo
It will be available across all strengths to match active drug in the form of tablet for oral administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs in Cohort 1
Timepoint [1] 0 0
Up to 64 days in Cohort 1
Primary outcome [2] 0 0
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 2
Timepoint [2] 0 0
Up to 30 days in Cohort 2
Primary outcome [3] 0 0
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 3
Timepoint [3] 0 0
Up to 30 days in Cohort 3
Primary outcome [4] 0 0
Part B: Number of Participants With SAEs and Non-SAEs
Timepoint [4] 0 0
Up to 25 days
Primary outcome [5] 0 0
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 1
Timepoint [5] 0 0
Up to 64 days in Cohort 1
Primary outcome [6] 0 0
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 2
Timepoint [6] 0 0
Up to 30 days in Cohort 2
Primary outcome [7] 0 0
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 3
Timepoint [7] 0 0
Up to 30 days in Cohort 3
Primary outcome [8] 0 0
Part B: Number of Participants With Abnormal Findings After Physical Examination
Timepoint [8] 0 0
Up to 25 days
Primary outcome [9] 0 0
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Timepoint [9] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2
Primary outcome [10] 0 0
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Timepoint [10] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2
Primary outcome [11] 0 0
Part B: Number of Participants With Abnormal ECG Findings
Timepoint [11] 0 0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 7 (Pre-dose, 4 Hours Post-dose), Day 14 (Pre-dose, 4 Hours Post-dose), Follow-up (Day 25)
Primary outcome [12] 0 0
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
Timepoint [12] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [13] 0 0
Part A: Change From Baseline in SBP and DBP in Cohort 2
Timepoint [13] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [14] 0 0
Part B: Change From Baseline in SBP and DBP
Timepoint [14] 0 0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
Primary outcome [15] 0 0
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Timepoint [15] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [16] 0 0
Part A: Change From Baseline in Pulse Rate in Cohort 2
Timepoint [16] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [17] 0 0
Part B: Change From Baseline in Pulse Rate
Timepoint [17] 0 0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
Primary outcome [18] 0 0
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Timepoint [18] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [19] 0 0
Part A: Change From Baseline in Body Temperature in Cohort 2
Timepoint [19] 0 0
Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3
Primary outcome [20] 0 0
Part B: Change From Baseline in Body Temperature
Timepoint [20] 0 0
Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)
Primary outcome [21] 0 0
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Timepoint [21] 0 0
Up to 64 days in Cohort 1
Primary outcome [22] 0 0
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Timepoint [22] 0 0
Up to 30 days in Cohort 2
Primary outcome [23] 0 0
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Timepoint [23] 0 0
Up to 30 days in Cohort 3
Primary outcome [24] 0 0
Part B: Average BSFS at Indicated Time Points
Timepoint [24] 0 0
Day -1, Days 1-3, Days 4-7, Days 1-7, Days 8-14
Primary outcome [25] 0 0
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Timepoint [25] 0 0
Baseline (Day -1) and Day 3
Primary outcome [26] 0 0
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Timepoint [26] 0 0
Baseline (Day -1) and Day 3
Primary outcome [27] 0 0
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Timepoint [27] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [28] 0 0
Part A: Change From Baseline in Erythrocytes in Cohort 1 and 3
Timepoint [28] 0 0
Baseline (Day -1) and Day 3
Primary outcome [29] 0 0
Part A: Change From Baseline in Erythrocytes in Cohort 2
Timepoint [29] 0 0
Baseline (Day -1) and Day 3
Primary outcome [30] 0 0
Part B: Change From Baseline in Erythrocytes
Timepoint [30] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [31] 0 0
Part A: Change From Baseline in Hemoglobin in Cohort 1 and 3
Timepoint [31] 0 0
Baseline (Day -1) and Day 3
Primary outcome [32] 0 0
Part A: Change From Baseline in Hemoglobin in Cohort 2
Timepoint [32] 0 0
Baseline (Day -1) and Day 3
Primary outcome [33] 0 0
Part B: Change From Baseline in Hemoglobin
Timepoint [33] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [34] 0 0
Part A: Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) in Cohort 1 and Cohort 3
Timepoint [34] 0 0
Baseline (Day -1) and Day 3
Primary outcome [35] 0 0
Part A: Change From Baseline in Erythrocyte MCV in Cohort 2
Timepoint [35] 0 0
Baseline (Day -1) and Day 3
Primary outcome [36] 0 0
Part B: Change From Baseline in Erythrocyte MCV
Timepoint [36] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [37] 0 0
Part A: Change From Baseline in Erythorocyte Mean Corpuscular Hemoglobin (MCH) in Cohort 1 and 3
Timepoint [37] 0 0
Baseline (Day -1) and Day 3
Primary outcome [38] 0 0
Part A: Change From Baseline in Erythrocyte MCH in Cohort 2
Timepoint [38] 0 0
Baseline (Day -1) and Day 3
Primary outcome [39] 0 0
Part B: Change From Baseline in Erythrocyte MCH
Timepoint [39] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [40] 0 0
Part A: Change From Baseline in Hematocrit in Cohort 1 and 3
Timepoint [40] 0 0
Baseline (Day -1) and Day 3
Primary outcome [41] 0 0
Part A: Change From Baseline in Hematocrit in Cohort 2
Timepoint [41] 0 0
Baseline (Day -1) and Day 3
Primary outcome [42] 0 0
Part B: Change From Baseline in Hematocrit
Timepoint [42] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [43] 0 0
Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3
Timepoint [43] 0 0
Baseline (Day -1) and Day 3
Primary outcome [44] 0 0
Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2
Timepoint [44] 0 0
Baseline (Day -1) and Day 3
Primary outcome [45] 0 0
Part B: Change From Baseline in ALT, AST and Alk Phos
Timepoint [45] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [46] 0 0
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3
Timepoint [46] 0 0
Baseline (Day -1) and Day 3
Primary outcome [47] 0 0
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2
Timepoint [47] 0 0
Baseline (Day -1) and Day 3
Primary outcome [48] 0 0
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Timepoint [48] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [49] 0 0
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Timepoint [49] 0 0
Baseline (Day -1) and Day 3
Primary outcome [50] 0 0
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Timepoint [50] 0 0
Baseline (Day -1) and Day 3
Primary outcome [51] 0 0
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Timepoint [51] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [52] 0 0
Part A: Change From Baseline in Albumin and Total Protein in Cohort 1 and 3
Timepoint [52] 0 0
Baseline (Day -1) and Day 3
Primary outcome [53] 0 0
Part A: Change From Baseline in Albumin and Total Protein in Cohort 2
Timepoint [53] 0 0
Baseline (Day -1) and Day 3
Primary outcome [54] 0 0
Part B: Change From Baseline in Albumin, Total Protein
Timepoint [54] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [55] 0 0
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Timepoint [55] 0 0
Baseline (Day-1) and Day 3
Primary outcome [56] 0 0
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Timepoint [56] 0 0
Baseline (Day -1) and Day 3
Primary outcome [57] 0 0
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Timepoint [57] 0 0
Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)
Primary outcome [58] 0 0
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Non-zero Concentration (AUC [0-t]) Following Single Dose Administration of GSK3352589
Timepoint [58] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [59] 0 0
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK3352589
Timepoint [59] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [60] 0 0
Part A: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of GSK3352589
Timepoint [60] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [61] 0 0
Part A: Time to Reach Cmax (Tmax) Following Single Dose Administration of GSK3352589
Timepoint [61] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [62] 0 0
Part A: Terminal Elimination Half-life (t1/2) Following Single Dose Administration of GSK3352589
Timepoint [62] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [63] 0 0
Part A: Cmax Following Single Dose Administration of GSK3352589-Food Effect
Timepoint [63] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [64] 0 0
Part A: AUC (0-t) Following Single Dose Administration of GSK3352589- Food Effect
Timepoint [64] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [65] 0 0
Part A: AUC (0-infinity) Following Single Dose Administration of GSK3352589- Food Effect
Timepoint [65] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose
Primary outcome [66] 0 0
Part B: AUC (0-t) Following Repeat Dose Administration of GSK3352589
Timepoint [66] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Primary outcome [67] 0 0
Part B: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC [0-24]) Following Repeat Dose Administration of GSK3352589
Timepoint [67] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Primary outcome [68] 0 0
Part B: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK3352589
Timepoint [68] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Primary outcome [69] 0 0
Part B: Cmax Following Repeat Dose Administration of GSK3352589
Timepoint [69] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14
Primary outcome [70] 0 0
Part B: Tmax Following Repeat Dose Administration of GSK3352589
Timepoint [70] 0 0
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14

Eligibility
Key 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 habits
* Male or Female of non-childbearing potential.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* Previous Diagnosis of IBS
* Estimated Glomerular Filtration Rate <60 millilter per minute per 1.73 square meter (mL/min/1.73m^2)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI) bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI surgery that could affect motility
* Unwillingness or inability to follow the procedures outlined in the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2018
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03154086