CYP2D6 phenotyping in vivax malaria relapsers and non-relapsers in Indonesia

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN37656897
• Date of registration: 16/05/2014
• Prospective Registration: No
• Primary sponsor: ALERTAsia Foundation (Indonesia)
• Public title: CYP2D6 phenotyping in vivax malaria relapsers and non-relapsers in Indonesia
• Scientific title: Case-control study of single-dose dextromethorphan CYP2D6 phenotype among patients previously dosed with primaquine and relapsing compared to those not relapsing
• Date of first enrolment: 15/05/2014
• Target sample size: 62
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37656897
• Study type: Interventional
• Study design: Open-label single-dose single-centre case-control study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

Indonesia

Contacts

• Name: Rianto Setiabudy

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Plasmodium vivax malaria

Intervention(s)

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 oral dose of dextromethorphan 30 mg (Kimia Farma Tbk, Bandung, Indonesia) on the morning of Day 0. Serial blood and urine samples will be collected for pharmacokinetic analysis of dextromethorphan (DXM) and dextrorphan, the dextromethorphan metabolite. Subjects will be confined beginning the day prior to dosing (Day 0) and may be discharged from the study unit following the 24-hour procedures. The subjects will be discharged from the study following the completion of all end of study procedures on Day 6 ± 1 day. Total blood volume taken during the study is 120 ml (8 tablespoons).

Primary Outcome(s)

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

Secondary ID(s)

CYP2D6 Phenotyping/EOCRU.2014.001/OXTREC 25-14

Source(s) of Monetary Support

Medicine for Malaria Venture (Switzerland)

Ethics review

Status:
Approval date:
Contact:

1. Medical Research Ethics Committee of Faculty of Medicine, University of Indonesia, 28/04/2014, No. 244/H2.F1/ETIK/2014 2. Oxford Tropical Research Ethics Committee, 01/05/2014, Oxtrec Reference 25-14

Results

• Results available: Yes
• Date Completed: 30/06/2014