Last updated: 11/07/2018 09:36:20

Pharmacokinetic (PK) profiles of tenofovir disoproxil fumarate (TDF) 300 mg in healthy Chinese subjectsPK of TDF

GSK study ID
115515
See study documents
Clinicaltrials.gov ID
NCT01480622
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: An open-label single and repeat dose study to investigate the pharmacokinetic profiles of tenofovir disoproxil fumarate 300 mg in healthy Chinese subjects
Trial description: This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China. This will be an open-label, single group, single and repeat dose study without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after the single dose and at steady state. The duration of the study will be approximately 7 weeks from screening to follow-up.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))

Timeframe: up to 60 hours after single dose

area under the concentration-time curve during steady state (AUC(0-τ))

Timeframe: up to 60 hours after repeat dose

Secondary outcomes:

adverse events (AEs)

Timeframe: up to 20 days, from the first dose until the follow-up contact

vital signs

Timeframe: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital

lab assessment

Timeframe: day 13, prior to discharge from hospital

12-lead electrocardiogram (ECG) parameters

Timeframe: day 13, prior to discharge from hospital

Interventions:
  • Drug: TDF tablets
    • Enrollment:
    14
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Chaoying Hu, Yanmei Liu, Yun Liu, Qian Chen, Wei Wang, Jingying Jia, Shixuan Sun, Chuan Lu, Kai Wu, Jie Li, Jane Dong, Chen Yu, Xuening Li . PharmacokineticsandTolerabilityofTenofovirDisoproxil Fumarate 300mgOnceDaily:AnOpen-Label,Single-and Multiple-Dose StudyinHealthyChineseSubjects. Clin Ther. 2013;35(12):1884-1889.
    Medical condition
    Hepatitis B, Chronic
    Product
    tenofovir disoproxil fumarate
    Collaborators
    Not applicable
    Study date(s)
    December 2011 to December 2011
    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
    • Male or female between 18 and 45 years of age
    • Positive result for hepatitis B, hepatitis C or HIV at screening
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy, as determined by a responsible and experienced physician
    • Male or female between 18 and 45 years of age
    • Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2
    Exclusion criteria:
    • Positive result for hepatitis B, hepatitis C or HIV at screening
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
    • Positive urine drug screen and breath alcohol test at screening or prior to dosing
    • Lactating females

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Shanghai, China, 200030
    Status
    Study Complete
    Contact us

    Study documents

    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
    2011-30-12

    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

    Participate in clinical trial
    Additional information
    Results for study 115515 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website