A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The study will investigate whether GSK1362885 is safe and well-tolerated when administered to normal healthy subjects. The study will also measure blood levels of the study drug to determine how the body processes the drug (pharmacokinetics) and what effects the drug has on the body (pharmacodynamics).

Key facts

Study ID

NCT00823940

Run by

GlaxoSmithKline

People needed

42

Starts

2009-01-13

Expected to finish

2009-04-27

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…

• A subject will be eligible for inclusion in this study only if all of the following criteria apply:
• Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• Male or female between 18 and 55 years of age, inclusive, at the time of signing the informed consent.
• 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
• BMI within the range 20.0 to 31.9 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Normal cardiac function and ECG parameters, as per protocol.
• No significant rhythm abnormalities in the Screening Holter ECG recording.

You may not qualify if…

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• The subject has a positive pre-study drug/alcohol screen. A minimum list of tobacco/drugs that will be screened include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• Urinary cotinine levels indicative of smoking 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 defined as an average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• History of glycogen storage disease
• Unable or unwilling to abstain from:
• Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices for 7 days prior to the first dose of study medication until the final post-dose assessment at each treatment level.
• 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
• Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
• Strenuous exercise for 48 hours prior to each blood collection for clinical laboratory tests. Subjects may participate in light recreational activities during studies (e.g., watch television, read).
• History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH and free T4 at screening
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.
• History of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound.
• Significant ECG abnormalities as defined per protocol
• Resting systolic blood pressure < 80 mmHg or > 150 or diastolic blood pressure < 60 mmHg or > 90 mmHg at screening. Resting heart rate is outside the range of 45 to 100 bpm.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody.
• A positive test for HIV antibody.
• A fasting triglyceride level >400mg/dL (4.45mmol/L).
• Anemia defined by hemoglobin concentration <11.0g/dL for males or <10.0g/lL for females.
• Significant renal disease as manifested by one or more of the following:
• Creatinine clearance <80 mL/min. (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
• Urine protein/creatinine (mg/mg) ratio >2.5; or urine albumin concentration >300 g/mg of creatinine.

Where it is running

• GSK Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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