NCT04080895

Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects

A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an open-label pharmacokinetic study in 16 healthy Thai subjects. To assess the safety and tolerability and pharmacological interactions of the combination of artemether-lumefantrine and amodiaquine. This study is funded by Prof White's WT PRF. The Welcome Trust grant reference number is B9R04920.

Detailed description

This study will enroll 16 healthy subjects both male and female, aged 18-60 years, at the Clinical Therapeutic Unit, Faculty of Tropical Medicine, Mahidol University. Subjects will be healthy HIV-1, hepatitis B and C uninfected individuals who comprehend the purpose of the study and have provided written consent. All subjects will undergo screening assessments (visit 1). Screening assessments (visit 1) may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to visit 2. If the interval between screening (visit 1) and day -1 visit 2 is three days or less, the clinical laboratory screening test result and serum pregnancy test result can be used for enrolment evaluation on day -1 visit 2. In such cases, these tests would not need to be repeated at day-1 visit 2. Visit 1 (Screening visit): All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast) including serum pregnancy testing (if appropriate) Visit 2-4: 16 healthy subjects who fulfill the eligibility criteria will be recruited and randomized to the study. All laboratory assessments (chemistry, hematology, FBS and urinalysis) must be drawn in the fasting state (8 hours fast). Results of these tests are to be available and reviewed prior to each subject receiving the study drug on day 0.

Conditions

• Pharmacokinetic
• Healthy
• Drug Combination

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine	Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
DRUG	Amodiaquine	Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks
DRUG	Artemether-lumefantrine	Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
DRUG	Artemether-lumefantrine + Amodiaquine	Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2019-09-06
• Last updated: 2026-01-12

Locations

1 site across 1 country: Thailand