Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
An Adaptive, Two Part, Two Period, Single Sequence, Drug Interaction Study Between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers
Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3
clinical development for the treatment of human immunodeficiency virus (HIV) infection. DTG
is primarily metabolized by UDP-glucuronosyltransferase (UGT1A1) with cytochrome P450
(CYP)3A4 pathway as a minor route. Corticosteroids have demonstrated induction effects on
UGTs and CYP3A4. Corticosteroids are often used in HIV-infected subjects and have the
potential to reduce DTG exposure due to enzyme induction when co-administered. The primary
objective of this study is to determine whether concomitant prednisone administration can
affect the pharmacokinetics (PK) of DTG.
The study is a two part, two period, open label study. Part 1 will evaluate the effect of a
high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the
results from Part 1. In Part 1, approximately 12 healthy subjects will receive DTG 50mg q24h
for 5 days in Period 1. Subjects will then be administered DTG 50mg q24h in combination with
prednisone 60mg for 5 days followed by a 5 day taper (total duration of 10 days) in Period
2. PK data of DTG will be obtained from Part 1 and used to inform decision making on the
need for Part 2. If DTG exposure is reduced by more than 50% in Part 1, Part 2 will be
carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in
Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed
by a 5 day taper (total duration of 10 days) in Period 2. Safety evaluations and serial PK
samples for DTG will be collected during each treatment period. A follow-up visit will occur
7-14 days after the last dose of study drug. All doses of study drugs will be taken
following a moderate fat meal. This study will be conducted at one center in the United
States, with healthy adult male and female subjects.
n/a
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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