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

Overview

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

Full Title of Study: “A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 27, 2009

Interventions

  • Drug: GSK1399686
    • Safety and tolerability dose escalation in normal human volunteers

Arms, Groups and Cohorts

  • Other: Part A
    • Single dose escalation
  • Other: Part B
    • 14 day repeat dose escalation
  • Other: Part C
    • Fixed dose food effect

Clinical Trial Outcome Measures

Primary Measures

  • • Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles
    • Time Frame: 72 hours and 14 days

Secondary Measures

  • PK parameters per protocol
    • Time Frame: 72 hours and 14 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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