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Determine the Tolerability and Safety of Atovaquone-proguanil (ATV-PG) Co-administered With Amodiaquine (AQ)

NCT04002687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-03-19

No results posted yet for this study

Summary

The aim of the study is to determine the tolerability and safety of ATV-PG + AQ, ATV-PG + AQ placebo, ATV-PG placebo + AQ, and ATV-PG placebo + AQ placebo administered once daily for 3 days to healthy adult male and female subjects.This study in healthy adults is the first step towards establishing the tolerability and safety of the approved doses of ATV-PG and AQ when co-administered. If considered acceptable based on the findings of this study, the tolerability, safety and PE will subsequently be assessed, within the target geographical areas.

Conditions

Interventions

DRUG

ATV-PG 1000-400 mg + AQ 612 mg

The dosing will be carried out by an unblinded member of the investigator's staff. Dosing will take place behind a curtain and during IMP administration the subjects will be blindfolded. ATV-PG (or placebo) will always be given first, then AQ (or placebo).

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Ulrike Lorch, MD FRCA FFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2019-10-29
Completion
2019-10-29

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002687 on ClinicalTrials.gov