Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Calcium Carbonate 1200 mg and Ferrous Fumarate 324 mg on Pharmacokinetics of Dolutegravir 50 mg in Healthy Adult Subjects
Human immune virus (HIV) infected subjects may take mineral supplements in combination with
their antiretroviral medications. Calcium and Iron supplementations are commonly used and
both of these have the potential to interact with Dolutegravir (DTG), this study will
evaluate the potential of calcium and iron supplements to decrease DTG exposure. It will
also evaluate two possible strategies for combined use; if an interaction is observed. The
first strategy is a two hour separation. The second strategy involves the administration of
DTG and the supplement with a meal since the presence of food modestly increases DTG
exposure, and because mineral supplements can be administered with food.
This is an open label, randomized, two cohort, four-period cross-over study in healthy
volunteers. One cohort will examine the effects of calcium carbonate and the other cohort
will examine the effects of ferrous fumarate on the pharmacokinetic (PK) of DTG.
Approximately 12 subjects will be enrolled into each of the two cohorts and receive each of
four treatments in a randomized fashion: 1) A single dose of DTG 50 milligram (mg)
administered under fasted conditions ; 2) A single dose of DTG 50 mg co-administered with a
single dose of calcium carbonate or ferrous fumarate under fasted conditions ; 3) A single
dose of DTG 50 mg co-administered with a single dose of calcium carbonate or ferrous
fumarate with a moderate-fat meal; 4) A single dose of DTG 50 mg administered under fasted
conditions 2 hours prior to administration of a single dose of calcium carbonate or ferrous
fumarate. There will be a washout period of at least 7 days between treatments. Safety
evaluations and serial PK samples will be collected during each treatment period. A
follow-up visit will occur 7-14 days after the last dose of study drug. This study will be
conducted at one center in the United States, with healthy adult male and female subjects.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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