At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single Blind, Placebo Controlled, Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of Ruxolitinib When Co-administered With Artemether-lumefantrine in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) and 20 mg/120 mg artemether-lumefantrine (AL) + Placebo for Malaria. Completed, enrolled 8 participants across 1 site.
Detailed Summary
Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics\& pharmacodynamics.
Study Details
Timeline
Interventions
Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).