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

Malaria Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT04456634
• Study type: Interventional
• Source: Medicines for Malaria Venture
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2020
• Completion date: November 17, 2020