Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase I, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Abacavir/Dolutegravir/Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC tablets have been extensively studied in subjects not of Japanese heritage, these parameters have not been exclusively assessed in Japanese subjects. To support the marketing application in Japan, this single-dose, open-label study will characterize the PK, safety and tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of 12 subjects will be enrolled such that approximately 10 evaluable subjects complete the study. The study will consist of a screening, treatment phase (single oral dose under the fasted state) and follow-up visit (within 7-14 days of the last PK sample collected). The total duration of the study for each subject will be approximately up to 48 days.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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