NCT04456634

Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomised, single-blinded, placebo-controlled, single centre, phase 1 trial. Eight healthy males or females, aged between 18-55 years old, who meet all of the inclusion criteria and none of the exclusion criteria, will be enrolled. The study will be composed of 2 groups to be enrolled sequentially. • Group 1a (sentinel group): two participants will be randomised single-blinded such that one participant will receive AL+Rux and the other participant will receive AL+placebo. After review of the safety and tolerability data up to and including Day 8 from Group 1a by the Safety Review Committee (SRC), a decision to proceed with Group 1b will be made. • Group 1b will be composed of 6 participants, to be randomised single-blinded such that five participants will receive AL+Rux, and one participant will receive AL+placebo.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)	Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
OTHER	20 mg/120 mg artemether-lumefantrine (AL) + Placebo	Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).

Timeline

• Start date: 2020-09-10
• Primary completion: 2020-11-17
• Completion: 2020-11-17
• First posted: 2020-07-02
• Last updated: 2021-07-09
• Results posted: 2021-07-09

Locations

1 site across 1 country: Australia