A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.

Completed · Phase 1 · Has a placebo group

Conditions studied: Dyslipidaemias

In brief

This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.

Key facts

Study ID

NCT00783549

Run by

GlaxoSmithKline

People needed

76

Starts

2008-09-04

Expected to finish

2009-03-31

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 prior to dosing
• Lactating females
• Has a fasting triglyceride level >400mg/dL (4.45mmol/L)
• Has anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/dL for females.
• CPK values higher than 2.5 times the upper limit of normal at screening.
• Significant ECG abnormalities
• abnormal vital signs as defined in the
• History of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound.
• Family history (first or second degree relatives) with a history of hypertrophic cardiomyopathy.
• Family history of torsade de pointes or other ventricular arrhythmias.
• Family history of unexplained sudden death.
• Evidence of early depolarization (e.g., Wolf-Parkinson-White syndrome).
• Has clinically significant rhythm abnormalities identified during 24-hour Screening Holter assessment.
• Subjects who have asthma or a history of asthma
• The subject has participated in a clinical trial and has received an investigational product within a protocol defined period

Where it is running

• GSK Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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