NCT02789566

Pharmacokinetic Study of Primaquine in Healthy Obese Thai Adult Subjects

Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Primaquine in Healthy Obese Thai Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to provide a description of the pharmacokinetic properties of primaquine and metabolites and characterize these in healthy obese Thai subjects. This is an open-label, single dose pharmacokinetic study in 10 healthy obese G6PD normal, subjects will be admitted as inpatient to receive 1 regimen for 1 visit only.

Detailed description

Subjects will have 1 hospitalization. The visit will require hospitalization for about 24 hours. After the screening (visit 1), the subject will receive Primaquine (PQ) 30 mg base single dose at first admission (visit 2). Assessment of the safety profile will be done after admission by the investigating team before proceeding to the regimen. The study will enroll 10 healthy obese subjects (Body mass index \[BMI\] ≥30 kg/m2) both male and female, age 18-60 years, from the pharmacokinetic unit at Faculty of Tropical Medicine, Mahidol University. Participants will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. Participants will be screened and eligibility will be based on inclusion and exclusion criteria. If all doses are completed without replacement of subjects, the total number of subjects in this study is 10. All subjects will undergo screening assessments within 7 days prior to the single dose to determine their eligibility for enrollment into the study.

Conditions

• Obese

Interventions

Type	Name	Description
DRUG	Primaquine	Primaquine 30 mg taken after meal in the morning.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-11-01
• Completion: 2012-12-01
• First posted: 2016-06-03
• Last updated: 2016-06-03

Locations

1 site across 1 country: Thailand