A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to I… (NCT00783549) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.
United States76 participantsStarted 2008-09-04
Plain-language summary
This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy Male or female between 18 and 55 years of age
* A female subject is eligible to participate if she is of non-childbearing potential
* Male subjects must agree to use one of the contraception methods listed in the protocol
* BMI within the range 20 - 29.9 kg/m2
* Capable of giving written informed consent, which includes compliance with protocol
* QTcB or QTcF \< 450msec.
Exclusion Criteria:
* The subject has a positive pre-study drug/alcohol screen
* Positive urinary cotinine levels or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* History of regular alcohol consumption within 6 months of the study
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Unable or unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
* Use of illicit drugs.
* Use of alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
* Consumption of red wine, oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacodynamic blood samples
* 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
* Pregnant females as determined by positive urine hCG test at screening or…
What they're measuring
1
Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Timeframe: Up to 4 days
2
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.