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Comparison of the ECG Effects Related to Pharmacokinetic Profile of Chloroquine and Piperaquine

NCT02192944 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-11-03

No results posted yet for this study

Summary

Chloroquine and piperaquine are the two most widely used antimalarial drugs ever. Hundreds of millions of people have received these drugs. Both are structurally similar and have cardiovascular effect. While there are no concerns over the use of chloroquine, regulatory authorities have suggested restrictions on the use of piperaquine.

We have recently completed a series of cross-over clinical and pharmacokinetic evaluations of chloroquine, piperaquine, pyronaridine and primaquine in healthy subjects. These studied were approved by the ethical committee of FTM. All drugs were well tolerated with no clinically significant ECG changes. Four subjects were in two studies. This offers a unique opportunity to compare the electrocardiographic effects of chloroquine and piperaquine in the same subjects and therefore characterize the concentration-effect relationships, and thus relative safety.

We propose to extend the previous subject study to recruit 16 subjects including those who have received either piperaquine or chloroquine in our previous studies so that 20 subjects received both drugs for a crossover comparison. The blood sampling schedule and electrocardiograms would be exactly the same as previously but would finish at 24 hours.

Conditions

  • Healthy

Interventions

DRUG

Chloroquine

Chloroquine base 600 mg single dose. To monitor ECG 12 lead at 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.

DRUG

Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine 120/960 mg single dose To monitor ECG 12 lead at: 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Borimas Hanboonkunupakarn, MD · Faculty of Tropical Medicine, Mahidol University, Thailand

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT02192944 on ClinicalTrials.gov