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Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and Albendazole (ABZ) in Healthy Subjects

NCT02568098 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-05-31

No results posted yet for this study

Summary

Primary Objective

* To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects.

Secondary Objectives

* To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and ABZ in healthy adult subjects.
* To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.
* To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM, ABZ and their metabolites.
* To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against Anopheles dirus and Anopheles minimus.
* To determine if IVM concentrations in venous blood differs from capillary blood.

Conditions

  • Drug Combination
  • Pharmacokinetics
  • Healthy

Interventions

DRUG

IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ

Regimen 1: IVM; Regimen 2: IVM and PQ; Regimen 3: IVM and DHA-PQP; Regimen 4: IVM and DHA-PQP and PQ;

DRUG

PQ and DHA-PQP and PQ

Regimen 5: PQ; Regimen 7: DHA-PQP and PQ

DRUG

DHA-PQP

Regimen 6: DHA-PQP

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Dr.Podjanee Jittamala, MD · Mahidol University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Thailand

Study Locations

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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 NCT02568098 on ClinicalTrials.gov