Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment

NCT ID: NCT03991208

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2021-05-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rest

Pharmacokinetics of Single Dose Malarone at Rest

Group Type: EXPERIMENTAL

Malarone

Intervention Type: DRUG

Malarone

Exercise

Pharmacokinetics of Single Dose Malarone under exercise in a heat chamber

Group Type: EXPERIMENTAL

Malarone

Intervention Type: DRUG

Malarone

Interventions

Malarone

Malarone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy adult female and male ages 18-44 weighing greater than 40kg with BMI less than 30.

Exclusion Criteria

17 years old or younger, 45 years old or older, unable to speak and read English, unable to perform exercise tests safely, and/or unable to consent to participate. Unwilling to undergo blood draws. Have known allergy to sunflower butter or are unwilling or unable to consume 2 tbsp or have an allergy to any component of malarone. Also non abstinent females at risk of becoming pregnant or in a heterosexual sexual relationships must be willing to use there chosen and available form of contraception defined as barrier protection, implantable device or hormones, or oral contraceptive pills during time of study up to 2 months after or abstinence unless previously sterile with tubal ligation 1 year or greater prior to screening or hysterectomy.

Initial screening for history will be performed by phone interview with requested waived consent. Those not able to achieve 80% pass on ICD test in 2 tries or less.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uniformed Services University

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

Walter_Reed

Identifier Type: -

Identifier Source: org_study_id