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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00721812
First received: July 22, 2008
Last updated: March 17, 2010
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Inflammatory Bowel Disease
 Drug: GSK1399686
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters per protocol [ Time Frame: 72 hours and 14 days ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part C
Fixed dose food effect
 Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers
Part A
Single dose escalation
 Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers
Part B
14 day repeat dose escalation
 Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721812

Locations
United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00721812     History of Changes
Other Study ID Numbers: 111406
Study First Received: July 22, 2008
Last Updated: March 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
IBD
first time in humans
Phase 1
 human volunteers
safety
pharmacokinetics

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013