Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects (PK of TDF)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01480622
First received: November 17, 2011
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: TDF tablets
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)) [ Time Frame: up to 60 hours after single dose ] [ Designated as safety issue: No ]
    AUC(0-t) of single dose

  • area under the concentration-time curve during steady state (AUC(0-τ)) [ Time Frame: up to 60 hours after repeat dose ] [ Designated as safety issue: No ]
    AUC(0-τ) during steady state


Secondary Outcome Measures:
  • adverse events (AEs) [ Time Frame: up to 20 days, from the first dose until the follow-up contact ] [ Designated as safety issue: No ]
    AEs accur during the study

  • vital signs [ Time Frame: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital ] [ Designated as safety issue: No ]
    blood pressure, pulse rate, respiratory rate and temperature

  • lab assessment [ Time Frame: day 13, prior to discharge from hospital ] [ Designated as safety issue: No ]
    Haematology, Clinical Chemistry and Routine Urinalysis

  • 12-lead electrocardiogram (ECG) parameters [ Time Frame: day 13, prior to discharge from hospital ] [ Designated as safety issue: No ]
    the heart rate and measures PR, QRS, QT and QTc intervals. All ECGs must be evaluated for safety by a qualified physician.


Enrollment: 14
Study Start Date: December 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TDF tablets
Tenofovir disoproxil fumarate tablets
Drug: TDF tablets
White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"
Other Name: TDF tablets

Detailed Description:

This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, single and repeat dose sessions and a follow-up contact.

The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.

Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.

The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.

Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.

Subjects completing the dosing sessions will not be required to visit the study centre for a follow-up visit, unless the Investigator determines that it is necessary for safety or other reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the last dosing to collect any information on concomitant medication taken and AEs experienced since the last visit.

The total duration of each subject's participation, from screening to follow-up contact, will be approximately 7 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480622

Locations
China
GSK Investigational Site
Shanghai, China, 200030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01480622     History of Changes
Other Study ID Numbers: 115515
Study First Received: November 17, 2011
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy subjects
Tenofovir disoproxil fumarate
hepatitis
pharmacokinetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014