A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects.

Phase 1

Active, not recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12614000781640
• Lead Sponsor: James McCarthy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Healthy volunteers

Exclusion Criteria

Any history of malaria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize the anti-malarial activity of ACT-451840 administered orally on clearance of Plasmodium falciparum blood stage parasites from the blood in healthy subjects.<br><br>Activities to be measured are antimalarial activity of ACT-451840 through bioassay; <br>[up to 16 days after administration of ACT-451840. ]

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of ACT-451840 in the challenge model - introduction of Plasmodium falciparum blood stage parasites in healthy subjects.<br><br>Outcome shall be assessed pharmacokinetics sampling. [144 hours post dose<br>];To assess the tolerability of ACT-451840 in the challenge model - vital signs (temperature, heart rate, blood pressure and respiratory rate), hematology, biochemistry and liver functin test, urinalysis, adverse event monitoring. [Up to 31 days after introduction of the Plasmodium falciparum blood stage parasites. ];To investigate ex vivo / in vitro antimalarial activity of ACT-451840 (bioassay)[144 hours post dose<br>]