Last updated: 11/07/2018 03:20:43

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

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GSK study ID
111406
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Clinicaltrials.gov ID
NCT00721812
EudraCT ID
2008-001215-38
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

• 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

Timeframe: 72 hours and 14 days

Secondary outcomes:

PK parameters per protocol

Timeframe: 72 hours and 14 days

Interventions:
Drug: GSK1399686
Enrollment:
87
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Schmith, V.D.; Zuo, P.; Padovan, J.; Stephens, K.; Kulkarni, S.; Oreskovic, K.. PREDICTING SYSTEMIC EXPOSURE IN HUMANS FOR A NOVEL DRUG WITH LOW ORAL BIOAVAILABILITY AND LOCAL ACTION IN THE GUT. American College of Clinical Pharmacology - 39th Annual Meeting. 2010;
Medical condition
Inflammatory Bowel Diseases
Product
GSK1399686
Collaborators
Not applicable
Study date(s)
September 2008 to May 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • 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.
  • 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
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-27-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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