A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

• Status: Completed
• Trial end date: 2012-10-01

Summary

This study will evaluate: (1) the effect of co-administration of single doses of calcium carbonate antacid and magnesium/aluminum hydroxide antacid on the steady-state plasma pharmacokinetic profile of raltegravir in human immunodeficiency virus (HIV)-infected participants; and (2) the effect of staggered dosing of a single dose of a magnesium/aluminum hydroxide antacid 2 hours before and 2 hours after administration of raltegravir on the steady-state plasma pharmacokinetic profile of raltegravir in the same participants.

The study will determine whether (1) the C12hrs of steady-state raltegravir after co-administration of single doses of calcium carbonate antacid is decreased to a clinically meaningful degree compared with C12hrs after administration of raltegravir alone; and whether (2) the C12hrs of steady-state raltegravir after co-administration of a single dose of magnesium/aluminum hydroxide antacid is decreased to a clinically meaningful degree compared with the C12hrs after administration of raltegravir alone.

• Phase: Phase 1

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aluminum Hydroxide; Aluminum hydroxide, magnesium hydroxide, drug combination; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; Antacids; Anti-Ulcer Agents; Calcium Carbonate; Magnesium Hydroxide; Raltegravir Potassium; TEMPO