A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686

• Status: Completed
• Trial end date: 2009-05-27
• Target enrollment: 0
• Participant gender: All

Summary

A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Healthy as determined by a responsible physician

• Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.

• Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).

• QTcB or QTcF < 450 msec

• Capable of giving written informed consent

Exclusion criteria:

• The subject has a positive pre-study drug/alcohol screen

• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units

• Urinary cotinine levels indicative of active smoking or regular use of tobacco

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody

• A positive test for HIV antibody

• The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product

• Exposure to more than four new chemical entities within 12 months

• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days

• Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days

• Subject is receiving hormone replacement therapy

• History of sensitivity to any of the study medications

• History of sensitivity to heparin or heparin-induced thrombocytopenia