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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: GSK1399686

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721812

111406

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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87 participants in 3 patient groups

Part A

Other group

Description:

Single dose escalation

Treatment:

Drug: GSK1399686

Part B

Other group

Description:

14 day repeat dose escalation

Treatment:

Drug: GSK1399686

Part C

Other group

Description:

Fixed dose food effect

Treatment:

Drug: GSK1399686