Effect of vicriviroc with or without ritonavir on oral contraceptive pharmacokinetics: a randomized, open-label, parallel-group, fixed-sequence crossover trial in healthy women.

Background: Because women of childbearing potential represent 20% to 25% of the HIV population, it is important to determine any potential drug interactions between vicriviroc, an antiretroviral agent, and an oral contraceptive (OC) to provide guidance on any potential dose adjustments.

Objective: The primary study objective was to determine the effect of vicriviroc, a C-C chemokine receptor type 5 inhibitor, alone or in the presence of ritonavir, on the pharmacokinetics (AUC and C(max)) of the study OC (ethinyl estradiol [EE] 0.035 mg + norethindrone [NET] 1 mg).

Assessment of the cardiac safety of fampridine-SR sustained-release tablets in a thorough QT/QTc evaluation at therapeutic and supratherapeutic doses in healthy individuals.

Objective: To characterize the effects of a sustained-release formulation of fampridine (fampridine-SR) on QT interval in healthy subjects.

Methods: In a double-blind, double-dummy trial, healthy subjects were randomized to 5 days treatment with fampridine-SR at therapeutic (10 mg twice daily) or supratherapeutic (30 mg twice daily) doses, placebo or moxifloxacin (400 mg on treatment day 5). Digital 12-lead electrocardiograms were recorded before treatment and on day 5; blood samples determined fampridine concentrations.