Obese Clinical Trial
Official title:
Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Primaquine in Healthy Obese Thai Adult Subjects
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.
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.
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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