Irritable Bowel SyndromePhase 1NCT02798991
A 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 Subjects
A Phase 1 study testing GSK3179106 in people with Irritable Bowel Syndrome, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- GSK3179106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2016to Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1. ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Estimated Glomerular Filtration Rate <60 milliliter 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, GI bleeding, GI surgery that could affect motility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, 14 Day, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Repeat Dose, Ascending Cohort Study to Evaluate the Safety, Tolerability Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- GSK3179106, Matched Placebo
- Keywords
- REarranged during Transfection Growth Factor Receptor Tyrosine Kinase Inhibitor
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3179106Drug
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 PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 10 mg of GSK3179106 QD-Cohort 1 | Experimental | Eligible six subjects will receive 10 mg oral dose once daily for 14 days Receives: Drug: GSK3179106 |
| 50 mg of GSK3179106 QD-Cohort 2 | Experimental | Eligible six subjects will receive 50 mg oral dose once daily for 14 days Receives: Drug: GSK3179106 |
| 200 mg of GSK3179106 QD-Cohort 3 | Experimental | Eligible six subjects will receive 200 mg oral dose once daily for 14 days Receives: Drug: GSK3179106 |
| 400 mg of GSK3179106 QD-Cohort 4 | Experimental | Eligible six subjects will receive 400 mg oral dose once daily for 14 days Receives: Drug: GSK3179106 |
| 25 mg of GSK3179106 BID-Cohort 5 | Experimental | Eligible six subjects will receive 25 mg oral dose twice daily for 14 days Receives: Drug: GSK3179106 |
| 200 mg of GSK3179106 BID-Cohort 6 | Experimental | Eligible six subjects will receive 200 mg oral dose twice daily for 14 days Receives: Drug: GSK3179106 |
| 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 Receives: Drug: Matched Placebo |
| 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 Receives: Drug: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse event (AE)
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
Measured: Up to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798991
- Sponsor's protocol ID
- 205181
- Status last verified
- Jan 2017
- First submitted
- 9 Jun 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooper M, O'Connor-Semmes R, Reedy BA, Hacquoil K, Gorycki P, Pannullo K, Verticelli A, Shakib S. First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):234-245. doi: 10.1002/cpdd.600. Epub 2018 Sep 13.
PubMed 30277655
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, 14 Day, Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Repeat Dose, Ascending Cohort Study to Evaluate the Safety, Tolerability Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02798991
- Acronym / sponsor ID
- 205181
- Conditions
- Irritable Bowel Syndrome
- Keywords
- REarranged during Transfection Growth Factor Receptor Tyrosine Kinase Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 10 mg of GSK3179106 QD-Cohort 1 | Experimental | Drug: GSK3179106Eligible six subjects will receive 10 mg oral dose once daily for 14 days |
| 50 mg of GSK3179106 QD-Cohort 2 | Experimental | Drug: GSK3179106Eligible six subjects will receive 50 mg oral dose once daily for 14 days |
| 200 mg of GSK3179106 QD-Cohort 3 | Experimental | Drug: GSK3179106Eligible six subjects will receive 200 mg oral dose once daily for 14 days |
| 400 mg of GSK3179106 QD-Cohort 4 | Experimental | Drug: GSK3179106Eligible six subjects will receive 400 mg oral dose once daily for 14 days |
| 25 mg of GSK3179106 BID-Cohort 5 | Experimental | Drug: GSK3179106Eligible six subjects will receive 25 mg oral dose twice daily for 14 days |
| 200 mg of GSK3179106 BID-Cohort 6 | Experimental | Drug: GSK3179106Eligible six subjects will receive 200 mg oral dose twice daily for 14 days |
| Matching placebo QD-Cohort 1, 2, 3, 4 | Placebo comparator | Drug: Matched PlaceboEligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days |
| Matching placebo BID-Cohort 5, 6 | Placebo comparator | Drug: Matched PlaceboEligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- ALT and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1. ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Estimated Glomerular Filtration Rate <60 milliliter 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, GI bleeding, GI surgery that could affect motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3179106It 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 | Drug | 10 mg of GSK3179106 QD-Cohort 1, 200 mg of GSK3179106 BID-Cohort 6, 200 mg of GSK3179106 QD-Cohort 3, 25 mg of GSK3179106 BID-Cohort 5, 400 mg of GSK3179106 QD-Cohort 4, 50 mg of GSK3179106 QD-Cohort 2 |
| Matched PlaceboIt 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 | Drug | Matching placebo BID-Cohort 5, 6, Matching placebo QD-Cohort 1, 2, 3, 4 |
Primary outcome
Number of subjects with adverse event (AE)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 30277655Cooper M, O'Connor-Semmes R, Reedy BA, Hacquoil K, Gorycki P, Pannullo K, Verticelli A, Shakib S. First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):234-245. doi: 10.1002/cpdd.600. Epub 2018 Sep 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3179106 in people with Irritable Bowel Syndrome, run by GlaxoSmithKline at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse event (AE) (time frame: Up to Day 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.