Status:
COMPLETED
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
Lead Sponsor:
GlaxoSmithKline
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00721812
Start Date
September 25 2008
End Date
May 27 2009
Last Update
July 7 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ