5 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
Part A: 52-week double-blind treatment phasePrimary* To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen Secondary* To assess cumulative…
To assess the efficacy of a single, oral, 3 grams (g) dose of zoliflodacin compared to a combination of a singleintramuscular (IM) 500 milligram (mg) dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment ofuncomplicated…