NCT02696954

Study of Artemether-lumefantrine, Amodiaquine and Primaquine in Healthy Subjects

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Primary Objective * To characterize the potential pharmacokinetic interactions of artemether -lumefantrine, amodiaquine and primaquine in healthy adult subjects. Secondary Objectives * To characterize the pharmacokinetic properties of artemether-lumefantrine, amodiaquine and primaquine when given alone and in combination. * To evaluate the safety and tolerability of co-administered artemether-lumefantrine, amodiaquine and primaquine. * To investigate pharmacogenetic polymorphisms affecting drug levels of artemether-lumefantrine, amodiaquine and primaquine and their metabolites.

Detailed description

The study design is an open-label pharmacokinetic study in healthy G6PD normal Thai subjects. This study will enroll 16 healthy subjects. Participants who pass the screening process will have 6 admissions in the hospital to receive 6 drug regimens as below First admission visit: The subject may be randomized to receive either Artemether-Lumefantrine or Amodiaquine with more than 6 weeks washout period before second admission visit. Second admission visit: Subject who receives Artemether-Lumefantrine from previous visit will receive amodiaquine in this visit and vice versa. This visit will required more than 6 weeks washout period before third admission visit. Third admission visit: Every subject will receive Artemether-lumefantrine and Amodiaquine with more than 6 weeks washout period before forth admission visit. Forth admission visit: Every subject will receive Primaquine with more than 1 week washout period before fifth admission visit. Fifth admission visit: Subject may randomize to receive either Artemether-Lumefantrine and Primaquine or Artemether-Lumefantrine and Amodiaquine and Primaquine in this visit with more than 6 weeks washout period before sixth admission visit. Sixth admission visit: Subject who receives Artemether-Lumefantrine and Amodiaquine and primaquine from previous visit will receive Artemether-Lumefantrine and Primaquine in this visit and vice versa.

Conditions

• Pharmacokinetic
• Drug Combination
• Healthy

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

Timeline

• Start date: 2016-11-18
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2016-03-02
• Last updated: 2019-06-28

Locations

1 site across 1 country: Thailand