Last reviewed · How we verify
NCT04002687
Determine the Tolerability and Safety of Atovaquone-proguanil (ATV-PG) Co-administered With Amodiaquine (AQ)
Phase 1 trial testing ATV-PG 1000-400 mg + AQ 612 mg in Malaria in 44 participants. Completed in 29 October 2019.
29 October 2019
Quick facts
| Lead sponsor | Medicines for Malaria Venture |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 44 |
| Start date | 4 April 2019 |
| Primary completion | 29 October 2019 |
| Estimated completion | 29 October 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- ATV-PG 1000-400 mg + AQ 612 mg — full drug profile →
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
Medicines for Malaria Venture — full company profile →
Who can join
Adults 18 to 45, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Unanticipated CNS Safety Signal in a Placebo-Controlled, Randomized Trial of Co-Administered Atovaquone-Proguanil and Amodiaquine.
Chalon S, Chughlay MF, Abla N, Marie Tchouatieu A, et al · · 2022 · cited 3× · PMID 34453327 · DOI 10.1002/cpt.2404
Verify or expand the search:
- PubMed search for NCT04002687
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Malaria
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
- NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting
Other Medicines for Malaria Venture trials
Trials by the same sponsor.
- NCT07011511 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combinati · Phase 1 · recruiting
- NCT06558643 — Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participant · Phase 1 · completed
- NCT05361486 — Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru · completed
- NCT05930782 — Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers. · Phase 1 · completed
- NCT05979207 — Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04002687 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medicines for Malaria Venture
- Last refreshed: 19 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04002687.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing