NCT03991208

Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Walter Reed Army Institute of Research (WRAIR) · Federal
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

A 2x2 randomized crossover of single dose malarone at rest and during moderate intensity exercise under controlled conditions of heat and humidity in healthy adult participants. Statistical analysis of AUC and Cmax will be performed to determine pharmacokinetic changes.

Detailed description

A clinical trial under controlled heat exposure and moderate intensity exercise, determined by VO2max testing and calibration, to determine if physiologic changes during heat exposure and exercise change the pharmacokinetics of malarone to a degree that falls outside the range of that which is considered bioequivalent or 80-125% concentration using AUC and Cmax for rate and extent of exposure. Participants will be randomized to order of rest and exercise components. Single dose malarone will be used during both arms. Single dose malarone pharmacokinetics will give insight into risk of toxicity or risk of under treatment during prophylaxis administration.

Conditions

• Exercise
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Malarone	Malarone

Timeline

• Start date: 2019-05-24
• Primary completion: 2021-05-23
• Completion: 2021-05-23
• First posted: 2019-06-19
• Last updated: 2021-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study