Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment

NCT03991208 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Walter_Reed
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Pharmacokinetics

Keywords

Pharmacokinetics; Exercise; Malaria Prophylaxis; Bioequivalence; Bioavailability

Outcome Measures

Primary Outcomes (2)

• AUC

  Area Under the Curve of Atovaquone, Proguanil, Cycloguanil

  216 hours

• Cmax

  Cmax of Atovaquone, Proguanil, Cycloguanil

  216 hours

Study Arms (2)

Rest

EXPERIMENTAL

Pharmacokinetics of Single Dose Malarone at Rest

Drug: Malarone

Exercise

EXPERIMENTAL

Pharmacokinetics of Single Dose Malarone under exercise in a heat chamber

Drug: Malarone

Interventions

Malarone DRUG

Malarone

Exercise; Rest

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead

Study Sites (1)

Uniformed Services University

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

atovaquone, proguanil drug combination

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 19, 2019
• Study Start: May 24, 2019
• Primary Completion: May 23, 2021
• Study Completion: May 23, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

US (1)