drugset / Trial / NCT02473367

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

NCT02473367

Phase 1 Completed 20 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

Summary

In order to define the safe windows for co-dosing of metal-cation antacids with once daily administered raltegravir, this study will evaluate the effect of both calcium carbonate and magnesium/aluminum hydroxide antacids on the pharmacokinetics of raltegravir, due to dosage of 1200 mg raltegravir in HIV-infected participants already taking 400 mg raltegravir twice daily as part of their HIV treatment regimen.

Timeline

Start
2015-06-23
Primary completion
2015-08-29
Completion
2015-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcium carbonate Other / unclassified Oral
Subject Raltegravir Other / unclassified 1200 mg Oral
Subject magnesium/aluminium hydroxide Unknown 20 ml Oral