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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00721812
First received: July 22, 2008
Last updated: July 5, 2017
Last verified: July 2017
July 22, 2008
July 5, 2017
September 25, 2008
May 27, 2009   (Final data collection date for primary outcome measure)
• 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 ]
Not Provided
Complete list of historical versions of study NCT00721812 on ClinicalTrials.gov Archive Site
PK parameters per protocol [ Time Frame: 72 hours and 14 days ]
GSK1399686 PK parameters AUC Cmax elimination and absorption rate constants terminal phase half life accumulation index and Cmax over 14 days
Not Provided
Not Provided
 
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 Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design
A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
Inflammatory Bowel Diseases
Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers
  • Part A
    Single dose escalation
    Intervention: Drug: GSK1399686
  • Part B
    14 day repeat dose escalation
    Intervention: Drug: GSK1399686
  • Part C
    Fixed dose food effect
    Intervention: Drug: GSK1399686
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
May 27, 2009
May 27, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00721812
111406
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP