Last updated: 11/07/2018 10:27:18

Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects

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GSK study ID
116416
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Clinicaltrials.gov ID
NCT01827631
EudraCT ID
Not applicable
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: Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Trial description: This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn’s disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Cmax

Timeframe: up to 72 hour post dose

AUC(0-τ)

Timeframe: up to 24 hour post last dose

Secondary outcomes:

adverse events (AEs)

Timeframe: up to 21 days, from the first dose until the follow-up visit

vital signs

Timeframe: before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic

lab assessment

Timeframe: Day 17 prior to leaving the clinic

Interventions:
  • Drug: GSK1605786 capsule
    • Enrollment:
    21
    Primary completion date:
    2013-14-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Sun Jing, Yaozong Yuan, Jie Li, Su Zhang, Ayla Cui, Kelly Dong, Tingting Fu, Sashi Gopaul, Lynda Haberer, Kai Wu.Single and Repeat-dose Pharmacokinetic Study of Vercirnon, a Potent Chemokine Receptor Antagonist in Healthy Chinese Subjects.Clinical Pharmacology in Drug Development.2014;3(S1):49 (3-96-1998248)
    Medical condition
    Crohn's Disease
    Product
    vercirnon
    Collaborators
    Not applicable
    Study date(s)
    May 2013 to June 2013
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
    • Male or female between 18 and 45 years of age
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    • Current or chronic history of liver disease, or known hepatic or biliary
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
    • Male or female between 18 and 45 years of age
    • Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2
    Exclusion criteria:
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    • Current or chronic history of liver disease, or known hepatic or biliary
    • A positive test for HIV antibody at screening
    • Known coeliac disease and positive serologic testing for anti-tTG antibodies
    • A positive pre-study drug/alcohol screen
    • Lactating females

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Shanghai, China, 200025
    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)
    Protocol
    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
    2013-14-06
    Actual study completion date
    2013-25-06

    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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