Malaria Infections and Infestations Plasmodium vivax malaria
Conditions
Interventions
All subjects will be screened up to no more than 10 days prior to study drug administration and fasted overnight (minimum of 8 hours) prior to study drug administration. Subjects will receive a single
Sponsors
ALERTAsia Foundation (Indonesia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 26 currently healthy subjects of OXTREC 179-12 who experienced a confirmed relapse of vivax malaria following directly observed primaquine therapy will be invited to enroll as cases in the current study 2. 36 currently healthy subjects of OXTREC 179-12 who did not experience a relapse of vivax malaria following directly observed primaquine therapy will be invited to enroll as controls in the current study 3. The subject must be able to read, understand, sign and date the IRB-approved Informed Consent Form for the current study prior to study participation 4. The subject must be judged to be in continued good health as determined by the investigator, based upon the results of a medical history, physical examination, vital signs and clinical laboratory profile 5. The subject must be able to comply with all study procedures including confinement at the investigative site and agree to participate in the entire study, returning for all visits 6. The subject must have normal clinical laboratory test results or, if abnormal, the results are not clinically significant in the investigator?s opinion, at Screening and on Day -1 7. Age 18 years or older, but younger than 65 years
Exclusion criteria
Exclusion criteria: 1. Subjects who have hypersensitivity to dextromethorphan or related compounds 2. Demonstrate a clinically significant finding from pre-treatment medical history, physical examinations, vital sign measurements, or clinical laboratory tests as determined by the investigator 3. Unwilling or unable to comply with the protocol or reside in the clinical research unit throughout the course of study 4. Has used any excluded medication, supplements or food product outlined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic parameters such as AUC0-24, AUC0-lqc, AUC0-inf, Cmax and Tmax will be estimated from plasma concentration-time data. Data from subjects prematurely ending participation in the study may be excluded from pharmacokinetic data evaluation 2. Odds ratios (ORs), 95% confidence interval (CI), and P values comparing proportions of CYP2D6 phenotype among relapsing patients compared to those not relapsing will be calculated using the Fisher?s exact test. The CI that included 1 and/or the P values that were >0.05 were considered insignificant | — |
Countries
Indonesia
Outcome results
None listed