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

NCT02696954 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-06-28

No results posted yet for this study

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.

Conditions

  • Pharmacokinetic
  • Drug Combination
  • Healthy

Interventions

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

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-18
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02696954 on ClinicalTrials.gov