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

Hepatitis B, Chronic Clinical Trial

— PK of TDF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480622
• Other study ID #: 115515
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2011
• Last updated: June 13, 2017
• Start date: December 5, 2011
• Est. completion date: December 30, 2011

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 30, 2011
• Est. primary completion date: December 30, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• TDF tablets
White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"

Locations

Country	Name	City	State
China	GSK Investigational Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))	AUC(0-t) of single dose	up to 60 hours after single dose
Primary	area under the concentration-time curve during steady state (AUC(0-t))	AUC(0-t) during steady state	up to 60 hours after repeat dose
Secondary	adverse events (AEs)	AEs accur during the study	up to 20 days, from the first dose until the follow-up contact
Secondary	vital signs	blood pressure, pulse rate, respiratory rate and temperature	day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
Secondary	lab assessment	Haematology, Clinical Chemistry and Routine Urinalysis	day 13, prior to discharge from hospital
Secondary	12-lead electrocardiogram (ECG) parameters	the heart rate and measures PR, QRS, QT and QTc intervals. All ECGs must be evaluated for safety by a qualified physician.	day 13, prior to discharge from hospital

External Links

•   Results for study 115515 can be found on the GSK Clinical Study Register.