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Type 2 Diabetes MellitusPhase 1NCT00495014

Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects

A Phase 1 study testing GSK376501 in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline at 1 site in United States.

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

This study represents the second Phase 1 study with GSK376501 and the goal is to further evaluate its safety and tolerability. The way the human body processes GSK376501 will also be determined. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
GSK376501
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
Jun 2007to Dec 2007
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The subject is healthy and overweight/obese, defined as having a body mass index greater than 25 but less than 35kg/m2, inclusive.
  • The subject is an adult male or a female of non-childbearing potential between the age of 18 and 65 years, inclusive, at the time of signing informed consent.
  • The subject and their partner are willing to use double-barrier method of contraception from the first day of study drug administration until 5 half-lives of the drug have elapsed following the last day of study drug administration.
  • The subject demonstrates an ECG with values within ranges specified in the protocol at screening or baseline.
  • The subject is capable of giving written informed consent, which includes the ability to read, comprehend and comply with the protocol requirements and restrictions as described in the consent form.

Who cannot join

  • Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any medication that is chemically related to the study drug or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation in the study.
  • Has a known allergy to any of the tablet formulation excipients of GSK376501 or pioglitazone (as applicable).
  • Has sensitivity to heparin or history of heparin-induced thrombocytopenia.
  • Has a history of alcohol abuse or dependence within 12 months prior to the study.
  • Has a positive alcohol test at screening or baseline and/or is unwilling to abstain from alcohol for 72 hours prior to the start of dosing until discharged from the clinic and for 72 hours prior to the follow-up visit.
  • Is unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to each dose and throughout each in-house period, and for 24 hours prior to the follow-up visit.
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  • The subject smokes or has used tobacco or nicotine-containing products within the 6 months prior to the study, or is positive for urine cotinine at screening or at baseline.
  • Is unwilling to refrain from the use of tobacco or illicit drugs during the trial, and/or tests positive for urine cotinine or drugs of abuse at screening or at baseline. At minimum, the list of drugs or classes of drugs that will be screened for include the following: amphetamines, barbiturates, benzoylecgonine, benzodiazepines, cannabinoids, cotinine, and opiates.
  • Where participation in the study would result in donation of blood in excess of 500 ml within a 56 day period.
  • Has a systolic blood pressure outside the range of 140 to 90mmHg, a diastolic blood pressure outside the range of 90 to 60mmHg and/or a heart rate outside the range of 90 to 45bpm, inclusive, at screening or at baseline.
  • Experiencing clinically significant ECG abnormalities at screening or at baseline.
  • Has a history or current evidence of a positive HIV test.
  • Has a history of or a positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Has laboratory safety screening tests outside of ranges specified in the protocol at screening or at baseline. T.
  • Pregnant or lactating women, or woman of childbearing potential.
  • Has a history of rhabdomyolysis.
  • Has congestive heart failure or a history of congestive heart failure with New York Heart Association Class I-IV symptoms
  • Has a history of thyroid dysfunction or an abnormal thyroid function test as assessed by TSH at screening.
  • Has a history or current evidence of sleep apnea.
  • Has had previous exposure to GSK376501, with the exception of subjects randomized into a previously completed study with GSK376501 may participate only in the cohort evaluating pioglitazone.
  • Has had treatment with any other new molecular entity (investigational drug) during the previous 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer), prior to the first dose of current study medication. For the purposes of this study, a new molecular entity is defined as any compound that has not yet reached Phase 3 development. The washout is defined from last dose of study medication in the previous study until the first dose of study drug.
  • Has been exposed to more than four new molecular entities within 12 months prior to the first dosing day.
  • Has used the following prescription or non-prescription medications within 14 days or 5 half lives, whichever is longer, prior to the first dose of study medication: vitamins (at a dose greater than the recommended daily allowance), or dietary or herbal supplements, including St. John's Wort.
  • Is unable or unwilling to discontinue use of acetaminophen 72 hours prior to each dose and throughout each in-house period and no use within 72 hours of the follow-up visit.
  • Requires the use of a prohibited medication .
  • Is unable or unwilling to abstain from the consumption of grapefruit or grapefruit juice for 7 days prior to the first dose of study medication until the final pharmacokinetic sample has been collected.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Evansville, Indiana, 47714

Other trials in United States

About this study

Official title: A Single-Blind, Randomized, Placebo-Controlled, Ascending Single Dose and Repeat Dose Study With Once Daily Dosing To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 in Healthy Overweight and Obese Subjects

This study represents the second Phase 1 study with GSK376501 and the goal is to further evaluate its safety and tolerability. The way the human body processes GSK376501 will also be determined.

Being tested
GSK376501, Placebo
Keywords
GSK376501,, Single Dose,, Dose Escalation,, Healthy Overweight/Obese Volunteer
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK376501Drug

  • PlaceboDrug

    Also called GSK376501

What is being measured

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

  1. Adverse reactions and changes in laboratory values, vital signs, and/or ECGs following each dose

    Measured: following each dose

Secondary outcomes (4)

  1. Blood levels of GSK376501 following 1 day (Part A) or 14 days (Part B) of dosing

    Measured: following 1 day (Part A) or 14 days (Part B) of dosing

  2. GSK376501 plasma levels to derive pharmacokinetic parameters following single and repeat doses for 14 days

  3. Standard markers that may serve as possible surrogates of volume expansions with GSK376501.

  4. Body weight following 14 days of repeat dosing with GSK376501.

Timeline

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

  1. First posted2 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00495014
Sponsor's protocol ID
DIX109981
Status last verified
Oct 2010
First submitted
28 Jun 2007
Last updated
15 Oct 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK376501 in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline at 1 site in United States.

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 5 inclusion and 26 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 15 Oct 2010. 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 States. 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 reactions and changes in laboratory values, vital signs, and/or ECGs following each dose (time frame: following each dose). 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 NCT00495014.

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 15 Oct 2010.

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