Correlation of CYP2D6 polymorphisms and pharmacokinetics of primaquine in Thai army Population on the Thailand-Cambodia border area

Phase 4

• Conditions: Thai armies who are at risk of malaria; Plasmodium vivax malaria, Primaquine, CYP2D6 polymorphisms, pharmacokinetics, Thai army population

• Registration Number: TCTR20190211002
• Lead Sponsor: Chulalongkorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-11
• Study Completion: 2020-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Male
• Target Recruitment: 345

Inclusion Criteria

For CYP2D6 gene analysis
1. Thai army male who has been performed in Thai-Cambodia border areas
2. Aged 18 to 60 years
3. Who had a history with malaria infection from the Thai-Cambodia border area (between January 1, 2012 and December 31, 2017)

For primaquine pharmacokinetics analysis
1. Participants in CYP2D6 gene analysis and known CYP2D6 status as PM, IM, NM
2. Aged 18 to 60 years
3. Who has a normal BMI (18 to 25 kg/m2)
4. Who has a normal physical examination

Exclusion Criteria

For primaquine pharmacokinetics analysis
1. Who continue receiving food supplement, herb, and medication regularly esp. CYP2D6 inhibitor(s), ABC transporter inhibitor esp. P-gp inhibitor(s)
2. Who received antimalarial treatment during the preceding 4 weeks
3. Who currently has malaria infection and signs of severe malaria
4. Who had an underlying disease that contraindication and/or precaution in primaquine using
5. Who had a history of gastrointestinal diseases, hepatic disease, kidney disease
6. Who knew a history of G6PD deficiency
7. Who is smoking
8. Who is drinking alcohol regularly; hazardous (8-15 scores), harmful (16 to 19 scores) and alcohol dependence (more than 20 scores) according to AUDIT
9. Who had a history of substance or drug addiction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PK parameters of primaqine (PQ) and 5,6-o-PQ in CYP2D6 genetic different Thai army population after drug administration LC-MS/MS

Secondary Outcome Measures

Name	Time	Method
Frequency of CYP2D6 genetic polymorphisms in Thai army population after participants signed informed consent Real-time PCR and Extra-long PCR