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

Inflammatory Bowel Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721812
• Other study ID #: 111406
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2008
• Last updated: July 5, 2017
• Start date: September 25, 2008
• Est. completion date: May 27, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 27, 2009
• Est. primary completion date: May 27, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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		72 hours and 14 days
Secondary	PK parameters per protocol		72 hours and 14 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 111406 can be found on the GSK Clinical Study Register.