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GastroparesisPhase 1NCT00562848

A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040

A Phase 1 study testing GSK962040 in people with Gastroparesis, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach). 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
48 participants
Where
1 siteBelgium
Study dates
10 Sep 2007to 27 Jun 2008
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 male or female subjects aged between 18 and 55 years inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
  • A female subject may be enrolled in the study regardless of whether she is currently of non-childbearing potential or of childbearing potential, as long as the following conditions are observed:
  • Females of non-childbearing potential: These are defined as females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation [Hatcher, 2004] or hysterectomy, or females who are post-menopausal.
  • Females of childbearing potential: These are defined as females, regardless of their age, with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes females with oligomenorrhea and females who are perimenopausal.
  • To be eligible for the study, the female of childbearing potential
  • must have a negative pregnancy test at screening before enrolment into the study; and
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  • must agree to use one of the highly effective methods for avoiding pregnancy in the protocol, from the Screening Visit throughout the duration of the study up to and including the follow-up clinic visit, which is anticipated to take place 7-10 days after the last dose of study medication (however the timing of the follow-up visit may be adjusted by File Note if it is indicated from the interim PK analyses). At this stage of development, there is no information on the potential pharmacokinetic interaction between GSK962040 and hormonal birth control methods, so the hormonal methods will not be acceptable.
  • A 12-lead ECG at pre-study screening, which in the opinion of the Principal Investigator or physician designee has no abnormalities that will compromise safety in this study. QT/QTc criteria are defined in the protocol.
  • A 24h Holter ECG at pre-study screening which in the opinion of the Principal Investigator or physician designee has no abnormalities that will compromise safety in this study.
  • Normal physical examination (physical exam demonstrates no evidence of clinically active disease or physical or mental impairment).
  • No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination.
  • Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive where BMI = Weight in kg (height in meters)2
  • The volunteer is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
  • Signed and dated written informed consent prior to the performance of any study related procedure.
  • Subjects will have negative Helicobacter pylori status or have received eradication within the last calendar year.

Who cannot join

  • Use of any hormonal method of contraception or any form of HRT (female subjects only).
  • History or presence of any clinically significant metabolic, gastrointestinal 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 of immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug, or other allergy that, in the opinion of the Principal Investigator or physician designee, contraindicates the subject's participation in the study. Additionally subjects with a known latex allergy should not be enrolled in C3.
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  • History or presence of corrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy are not eligible).
  • Abnormal TSH or free T4 at screening/baseline.
  • Unwillingness to commit to avoid excessive exposure to sunlight (or exposure whilst on a tanning bed) which would cause a sunburn reaction from Day -1 up to and including the follow-up visit.
  • A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
  • History or presence of abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
  • History or presence of recreational drug abuse or dependence.
  • The subject has a positive pre-dose urine drug or alcohol breath test. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
  • If the subject is a tobacco smoker: An unwillingness to commit to stable and moderate use (as determined by the Investigator) of tobacco or nicotine-containing products, including nicotine patches/gum, during the course of the study.
  • Consumption of grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until the follow-up visit.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 3 weeks prior to the first dose of study medication until final evaluation, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • Has received an investigational drug or has participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Where participation in study would result in donation of blood in excess of 500 ml within a 56 day period.
  • For male volunteers: An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 90 days following administration of the last dose of study medication.
  • History of or current lactose intolerance.
  • Women who are pregnant or breast-feeding.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A First-Time-in-Human Randomized Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of the Oral Motilin Receptor Agonist GSK962040, in Male and Female Healthy Subjects

Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore provide a potential approach to the treatment of a range of clinical conditions where delayed gastric emptying may contribute to symptoms, such as enteral feeding intolerance (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and functional dyspepsia.

This study is the First Time In Human study for the motilin receptor agonist, GSK962040.

Conditions
Gastroparesis
Being tested
GSK962040, Placebo
Keywords
gastric emptying, pharmacokinetic, tolerability, safety, GSK962040, gut motility, First Time in Human
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 will be supplied in the following tablet strengths: 1 milligram, 5m milligrams, 25 milligrams, 125 milligrams.

  • PlaceboDrug

    Subjects will receive placebo.

Study groups in NCT00562848
Study groupRoleWhat they receive
Subjects enrolled in single dose escalation cohortExperimentalSubjects will receive escalated doses of GSK962040 with a starting dose of 1 milligrams along with placebo in fasted state.
Receives: Drug: GSK962040; Drug: Placebo
Subjects enrolled in gastric emptying cohortExperimentalSubjects will receive escalated doses of GSK962040 with a starting dose of 1 milligrams along with placebo in fasted state.
Receives: Drug: GSK962040; Drug: Placebo
Subjects enrolled in gastro-enteral contractility cohortExperimentalEligible subjects will receive GSK962040 and placebo in the fasted state in crossover manner.
Receives: Drug: GSK962040; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events -

    Measured: for 5 days

  2. Gastrointestinal symptoms -

    Measured: for 6 hours

  3. Blood pressure, heart rate, electrocardiography -

    Measured: for 48 hours

  4. Clinical chemistry/haematology -

    Measured: for 5 days

  5. Plasma pharmacokinetic parameters -

    Measured: for 5 days

Secondary outcomes (3)

  1. Measurement of gastric emptying for 4.5 hours post-dose

    Measured: 4.5 hours post-dose

  2. Measurement of stomach muscle activity for 24 hours post-dose

    Measured: 24 hours post-dose

  3. Measurement of plasma pharmacokinetic and other blood tests for 3.5 hours post-dose

    Measured: 3.5 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2007 (estimated)
  2. Study start10 Sep 2007
  3. Primary completion27 Jun 2008
  4. Study completion27 Jun 2008

Resources

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
Crossover
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00562848
Sponsor's protocol ID
MOT107043
Status last verified
Aug 2017
First submitted
21 Nov 2007
Last updated
8 Aug 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.

Publications

  • Deloose E, Depoortere I, de Hoon J, Van Hecken A, Dewit OE, Vasist Johnson LS, Barton ME, Dukes GE, Tack J. Manometric evaluation of the motilin receptor agonist camicinal (GSK962040) in humans. Neurogastroenterol Motil. 2018 Jan;30(1). doi: 10.1111/nmo.13173. Epub 2017 Aug 6.

    PubMed 28782145

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 Belgium.

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 15 inclusion and 22 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 8 Aug 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 Belgium. 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. 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?

Adverse Events - (time frame: for 5 days). The study lists 5 primary outcomes in all. 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 NCT00562848, 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 8 Aug 2017.

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