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
See study documents
Clinicaltrials.gov ID
NCT00721812
EudraCT ID
2008-001215-38
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Harrow, Middlesex, United Kingdom, HA1 3UJ
    Status
    Study Complete
    Contact us

    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
    Study complete
    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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