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NCT Number: NCT00721812

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK1399686

Drug

Safety and tolerability dose escalation in normal human volunteers

Primary outcomes

  1. • 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 outcomes

  1. PK parameters per protocol

    Time frame: 72 hours and 14 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2008
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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