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

NCT01480622 | Completed Phase 1

• 1 other identifier: 115515
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B, Chronic

Keywords

healthy subjects; Tenofovir disoproxil fumarate; hepatitis; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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

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

  AUC(0-τ) during steady state

  up to 60 hours after repeat dose

Secondary Outcomes (4)

• adverse events (AEs)

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

• vital signs

  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

  day 13, prior to discharge from hospital

• 12-lead electrocardiogram (ECG) parameters

  day 13, prior to discharge from hospital

Study Arms (1)

TDF tablets

EXPERIMENTAL

Tenofovir disoproxil fumarate tablets

Drug: TDF tablets

Interventions

TDF tablets DRUG

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

TDF tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Shanghai, 200030, China

Location

Related Publications (1)

• Hu CY, Liu YM, Liu Y, Chen Q, Wang W, Wu K, Dong J, Li J, Jia JY, Lu C, Sun SX, Yu C, Li X. Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects. Clin Ther. 2013 Dec;35(12):1884-9. doi: 10.1016/j.clinthera.2013.09.020. Epub 2013 Oct 19.

  PMID: 24148552 DERIVED

Related Links

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

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 29, 2011
• Study Start: December 5, 2011
• Primary Completion: December 30, 2011
• Study Completion: December 30, 2011
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

CN (1)