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A Study to Assess the Availability of Oral Primaquine and Its Inert Metabolite, Carboxyprimaquine, in the Body

NCT05938608 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-05-06

No results posted yet for this study

Summary

An open-label pharmacokinetic study. This study will enroll 20 healthy adult subjects (10 males and 10 females aged 18-60 years) at the Clinical Therapeutics Unit or inpatient ward, Faculty of Tropical Medicine, Mahidol University, Thailand.

The investigator propose to conduct a definitive bioavailability and pharmacokinetic study in healthy adult volunteers, both male and female, with normal CYP2D6 genotypes to assess oral primaquine bioavailability by the administration of intravenous and oral primaquine on different days and calculate the proportion of drug converted to its inactive metabolite, carboxyprimaquine, in order to estimate the proportion of its active metabolites. The intravenous injection of the known amount of carboxyprimaquine will allow the calculation of carboxyprimaquine's volume of distribution.

Conditions

  • Healthy
  • Pharmacokinetic

Interventions

DRUG

Regimen 1 (Oral primaquine)

Primaquine 15 mg base orally once

DRUG

Regimen 2 (IV primaquine phosphate)

Primaquine 7.5 mg base in normal saline 500 mL infused over 30 minutes intravenously

DRUG

Regimen 3 (IV carboxyprimaquine)

Carboxyprimaquine 7.93 mg base in normal saline 500 mL infused over 30 minutes intravenously

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Mahidol University

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Borimas Hanboonkunupakarn, Asst. Prof · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2025-03-31

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 NCT05938608 on ClinicalTrials.gov