Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an initial efficacy study of a candidate antimalarial in human subjects with
      uncomplicated malaria caused by the most common and most important parasite in Africa
      (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P.
      falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug
      (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem
      twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly
      effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both
      chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of
      Orphan Product Development (OOPD).
    

Detailed description: 
      This is an initial efficacy study (Phase 2 Proof of Concept Study) of a candidate
      antimalarial in human subjects with uncomplicated malaria caused by the most common and most
      important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian
      males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg
      of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment,
      which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. The
      hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the
      treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and
      chloroquine-resistant parasites.
    

Intervention name(s): AQ-13 Treatment; Coartem Treatment
Intervention type(s): Drug; Drug
Intervention description(s): Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days.; Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coartem tablets over 3 days (each dose containing 80 mg artemether and 480 mg lumefantrine). Those six doses will be given at the time of diagnosis and 8 hours later on day 1, at 24 and 36 hours on day 2 and at 48 and 60 hours on day 3 for total doses of 480 mg artemether and 2880 mg lumefantrine over 3 days.
Other intervention name(s): N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine.; Tablets contain 20 (or 80) mg artemether and 120 (or 480) mg lumefantrine.
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plasmodium falciparum; pharmacokinetics; antimalarials (antimalarial drugs); chloroquine (chloroquine-resistant); QT (QTc) interval