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

Sponsor
Medicines for Malaria Venture
Study ID
NCT04456634
Phase
PHASE1
Status
Completed

Conditions

  • Malaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 10, 2020
Status verified
Jun 2021
Primary completion
Nov 17, 2020
Completion
Nov 17, 2020

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AL&RUX
    Oral administration of: • 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)
  • Placebo Comparator: AL& Placebo
    20 mg/120 mg artemether-lumefantrine (AL) + Placebo

Primary Outcome Measure

Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen. [ Time Frame: up to 28 days after AL+Rux and AL+placebo administration ]

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