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Type 2 Diabetes MellitusPhase 1NCT00605449

A Drug Interaction Study Between Simvastatin and GSK376501

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 is a 3-period crossover drug interaction study between GSK376501 and simvastatin in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the pharmacokinetics of GSK375601. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
GSK376501
How many people
39 participants
Where
1 siteUnited States
Study dates
Jan 2008to Mar 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 as determined by a responsible 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 considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male or female between 18 and 55 years of age.
  • 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 and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
  • Body weight ≥ 50 kg and BMI within the range 19 - 30 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Demonstrates an average QTc interval < 450 msec (or < 480 msec in subjects with Bundle Branch Block), an average PR interval < 200 msec, and a QRS duration < 110msec (manual or machine read) at screening or baseline

Who cannot join

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive test for HIV antibody.
  • 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.
  • Previous exposure to GSK376501.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
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  • Subjects will be excluded if they experience symptomatic or asymptomatic arrhythmia of any clinical significance during screening.
  • The subject has a positive pre-study drug/alcohol screen and is unwilling to abstain from 72 hours prior to dose until follow-up. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Urinary cotinine levels indicative of smoking or history or use of tobacco or nicotine-containing products within 6 months prior to screening.
  • Has a history of alcohol abuse or dependence within 12 months prior to the study. Alcohol abuse is defined as an average consumption of greater than 7 drinks per week for women or greater than 14 drinks per week for men. One alcohol drink is defined as the equivalent of 12 g of alcohol as follows: 5 oz/150 ml wine, 12 oz (360 ml) beer or 1.5 oz (45 ml) of 80 proof distilled spirits.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort, kava, ephedra [ma huang], gingko biloba, DHEA, vohimbe, saw palmetto, ginseng, red yeast rice) 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 and is unwilling to abstain from use of these medications until the last pharmacokinetic sample has been collected, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Use of caffeine- or xanthine-containing products for 24 hours prior to the start of dosing until collection of the final pharmacokinetic and sample of each study period.
  • Consumption of any food or any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, Seville oranges, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats from 7 days prior to the first dose of study medication until the last pharmacokinetic sample has been collected.
  • Use of acetaminophen within 48 hours of the first dose and is unable or unwilling to discontinue use of acetaminophen until the last pharmacokinetic sample has been collected.
  • Use of aspirin, aspirin-containing compounds, salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours days of the first dose and is unwilling to abstain from use of these medications until the last pharmacokinetic sample has been collected.
  • Use of liquid antacids (e.g. Maalox, Mylanta, Amphogel, milk of magnesia) or chewable antacids (e.g. TUMS) within 48 hours of the first dose and is unwilling to abstain from use of these medications until the last dose of study medication.
  • 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.
  • Alkaline phosphatase value higher than 1.5 times the upper limit of normal at screening or at baseline.
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct (conjugated) bilirubin, or CPK values higher than 1.25 times upper limit of normal at screening or at baseline.
  • Fasting triglyceride level > 400 mg/dL (4.52 mmol/L) at screening or at baseline.
  • Donation of blood or blood products in excess of 500 mL within a 56 day period.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History of rhabdomylosis.
  • History of or current congestive heart failure (NYHA Class I-IV symptoms - refer to Appendix 3)
  • History of thyroid dysfunction or an abnormal thyroid function test as assessed by TSH as screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: Phase I, Randomized, Open-Label, 3 Period Crossover Drug Interaction Study Between Simvastatin and GSK376501 in Healthy Subjects

This study is a 3-period crossover drug interaction study between GSK376501 and simvastatin in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the pharmacokinetics of GSK375601.

Being tested
GSK376501
Keywords
GSK376501, Simvastatin, Healthy Subjects, Repeat Dose, Drug Interaction, Randomized, Pharmacokinetics
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

What is being measured

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

  1. drug plasma levels of GSK376501:

    Measured: Day 7 Periods 1, 2 & 3

Secondary outcomes (7)

  1. drug plasma levels of GSK376501:

    Measured: Day 7 all periods

  2. adverse events, vital signs, con meds:

    Measured: each visit, all periods

  3. labs:

    Measured: Days 4 & 8 all periods

  4. ECGs:

    Measured: Days 1-7 all periods

  5. Simvastatin acid Day 7 tmax and t1/2.

  6. Simvastatin Day 7 AUC(0-24), Cmax, tmax and t1/2.

  7. GSK376501 Day 7 AUC(0-24), Cmax, tmax and t1/2.

Timeline

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

  1. First posted31 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2008
  4. Study completionMar 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
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605449
Sponsor's protocol ID
DIX109980
Status last verified
Oct 2010
First submitted
18 Jan 2008
Last updated
19 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 8 inclusion and 25 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 19 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?

drug plasma levels of GSK376501: (time frame: Day 7 Periods 1, 2 & 3). 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 NCT00605449.

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 19 Oct 2010.

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