GastroparesisPhase 1NCT00733551
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK962040 Administered to Healthy Adult Subjects.
A Phase 1 study testing GSK962040 in people with Gastroparesis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses of GSK962040. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GSK962040
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2008to 20 Jul 2009
- 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
- Healthy as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. In any case, liver function tests must be strictly within the normal range at screening.
- Male or female between 18 and 55 years of age, inclusive.
- Non-smoker for at least 6 months based on smoking history.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL is confirmatory.
- Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for at least 4 days following the last dose of study medication.
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- Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication through at least 4 days after the last dose of study medication.
- Body weight > 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
- QTcB or QTcF < 450 msec or QTc<480msec in subjects with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period.
- Normal physical examination (physical exam demonstrates no evidence of clinically active disease or physical or mental impairment). A subject with a clinical abnormality may be included only if the Principal Investigator or physician designee considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures. Consultation with the GSK medical monitor is required before such subjects may be included.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subjects will have negative Helicobacter pylori status or have received eradication within the last calendar year.
Who cannot join
- History or presence of any clinically significant metabolic condition, gastrointestinal (including passing of > 3 stools/ day or <3 stools/week) condition or endocrinological condition.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of major gastrointestinal surgical procedure within the last 10 years.
- History of cholecystectomy or biliary tract disease.
- History or presence of thyroid dysfunction (NOTE: subjects with abnormal TSH at screening/baseline or hypothyroidism on a stable dose of thyroid replacement therapy are not eligible).
- A history or presence of recreational drug abuse or dependence or current abuse as evidenced by positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
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- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- History of regular alcohol consumption within 6 months of the study defined as:
- An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to approximately a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test (from the first urine of the day) at screening or prior to dosing.
- Lactating or pregnant females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- For male volunteers: An unwillingness of the male subject to comply with the contraception requirements listed in the protocol, from the time of the first dose of study medication until at least 4 days following administration of the last dose of study medication.
- History of or current lactose intolerance.
- Subjects recruited for/participating in Cohorts 2-5 will be screened such that subjects exhibiting rapid gastric emptying rates will be excluded, as defined by the reference range of baseline gastric emptying rate (t1/2b) observed in cohort 1.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this study
Official title: A Randomized, Double-blind, Ascending Dose Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Repeat Doses of Motilin Receptor Agonist GSK962040 in Male and Female Healthy Volunteers
This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses of GSK962040.
- Conditions
- Gastroparesis
- Being tested
- GSK962040, Placebo
- Keywords
- motilin, gastric emptying, GSK962040, oral dose
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK962040Drug
GSK962040 tablets will be available in dosing strengths of 1 milligram, 5 milligrams, 25 milligrams given orally, once daily, in the morning, in a fasted state.
PlaceboDrug
Placebo tablets will be given orally, once daily, in the morning, in a fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GSK962040 in cohort 1 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 10 milligrams once daily tablet for 14 days. Receives: Drug: GSK962040; Drug: Placebo |
| Subjects receiving GSK962040 in cohort 2 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 30 milligrams once daily tablet for 14 days. Receives: Drug: GSK962040; Drug: Placebo |
| Subjects receiving GSK962040 in cohort 3 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 100 milligrams once daily tablet for 14 days. Receives: Drug: GSK962040; Drug: Placebo |
| Subjects receiving placebo in cohort 1, 2 and 3 | Placebo comparator | Eligible subjects will receive repeat oral doses of placebo tablets given once daily for 14 days in cohort 1, 2 and 3. Receives: Drug: GSK962040; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and PK of GSK962040 from all adverse event reporting, 12-lead ECGs, vital signs, observation, safety laboratory tests and GI symptom diary; (AUC, Cmax, Tmax, accumulation ratio (Ro), half life and time invariance ratio (Rs)).
Secondary outcomes (5)
Effect on gastric emptying.Effect of liquid meal on PK of GSK962040. Effect on bowel movement parameters
Pharmacokinetic parameters following repeated oral doses of GSK962040 during a simulated liquid enteral feed meal: Cmax, Tmax, and AUC(0-t)
Gastric emptying, as measured by the 13C octanoic acid breath test:Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC)
Bowel movement parameters: Time to first bowel movement after first dose, Daily bowel movement count, Daily average bowel movement Bristol Stool Form scale
Pharmacokinetic parameters following repeated every other day (QOD) oral doses of GSK962040: Cmax, Tmax, AUC(0-t), accumulation ratio (Ro), and, if possible, half-life, and time invariance ratio (Rs), as needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start23 Sep 2008
- Primary completion20 Jul 2009
- Study completion20 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 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
- NCT00733551
- Sponsor's protocol ID
- MOT109681
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2008
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Ascending Dose Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Repeat Doses of Motilin Receptor Agonist GSK962040 in Male and Female Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00733551
- Acronym / sponsor ID
- MOT109681
- Conditions
- Gastroparesis
- Keywords
- motilin, gastric emptying, GSK962040, oral dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2008 (actual)
- Primary completion
- 20 Jul 2009 (actual)
- Study completion
- 20 Jul 2009 (actual)
- First posted
- 13 Aug 2008 (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.
This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses of GSK962040.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GSK962040 in cohort 1 | Experimental | Drug: GSK962040, Drug: PlaceboEligible subjects will receive repeat oral doses of GSK962040 given as 10 milligrams once daily tablet for 14 days. |
| Subjects receiving GSK962040 in cohort 2 | Experimental | Drug: GSK962040, Drug: PlaceboEligible subjects will receive repeat oral doses of GSK962040 given as 30 milligrams once daily tablet for 14 days. |
| Subjects receiving GSK962040 in cohort 3 | Experimental | Drug: GSK962040, Drug: PlaceboEligible subjects will receive repeat oral doses of GSK962040 given as 100 milligrams once daily tablet for 14 days. |
| Subjects receiving placebo in cohort 1, 2 and 3 | Placebo comparator | Drug: GSK962040, Drug: PlaceboEligible subjects will receive repeat oral doses of placebo tablets given once daily for 14 days in cohort 1, 2 and 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy as determined by a physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. In any case, liver function tests must be strictly within the normal range at screening.
- Male or female between 18 and 55 years of age, inclusive.
- Non-smoker for at least 6 months based on smoking history.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL is confirmatory.
Key exclusion criteria (20 listed)
- History or presence of any clinically significant metabolic condition, gastrointestinal (including passing of > 3 stools/ day or <3 stools/week) condition or endocrinological condition.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of major gastrointestinal surgical procedure within the last 10 years.
- History of cholecystectomy or biliary tract disease.
- History or presence of thyroid dysfunction (NOTE: subjects with abnormal TSH at screening/baseline or hypothyroidism on a stable dose of thyroid replacement therapy are not eligible).
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 |
|---|---|---|
| GSK962040GSK962040 tablets will be available in dosing strengths of 1 milligram, 5 milligrams, 25 milligrams given orally, once daily, in the morning, in a fasted state. | Drug | Subjects receiving GSK962040 in cohort 1, Subjects receiving GSK962040 in cohort 2, Subjects receiving GSK962040 in cohort 3, Subjects receiving placebo in cohort 1, 2 and 3 |
| PlaceboPlacebo tablets will be given orally, once daily, in the morning, in a fasted state. | Drug | Subjects receiving GSK962040 in cohort 1, Subjects receiving GSK962040 in cohort 2, Subjects receiving GSK962040 in cohort 3, Subjects receiving placebo in cohort 1, 2 and 3 |
Primary outcome
Safety, tolerability, and PK of GSK962040 from all adverse event reporting, 12-lead ECGs, vital signs, observation, safety laboratory tests and GI symptom diary; (AUC, Cmax, Tmax, accumulation ratio (Ro), half life and time invariance ratio (Rs)).
5 secondary outcomes
Effect on gastric emptying.Effect of liquid meal on PK of GSK962040. Effect on bowel movement parameters
Pharmacokinetic parameters following repeated oral doses of GSK962040 during a simulated liquid enteral feed meal: Cmax, Tmax, and AUC(0-t)
Gastric emptying, as measured by the 13C octanoic acid breath test:Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC)
Bowel movement parameters: Time to first bowel movement after first dose, Daily bowel movement count, Daily average bowel movement Bristol Stool Form scale
Pharmacokinetic parameters following repeated every other day (QOD) oral doses of GSK962040: Cmax, Tmax, AUC(0-t), accumulation ratio (Ro), and, if possible, half-life, and time invariance ratio (Rs), as needed.
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 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study MOT109681 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK962040 in people with Gastroparesis, run by GlaxoSmithKline at 1 site in United Kingdom.
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 12 inclusion and 20 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 Jul 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 United Kingdom. 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?
Safety, tolerability, and PK of GSK962040 from all adverse event reporting, 12-lead ECGs, vital signs, observation, safety laboratory tests and GI symptom diary; (AUC, Cmax, Tmax, accumulation ratio (Ro), half life and time invariance ratio (Rs)).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2017.