Primaquine Enantiomers in G6PD Deficient Human Volunteers

NCT ID: NCT04073953

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-09-01

Brief Summary

This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days.

Detailed Description

Each subject will receive a 15 mg dose of one enantiomer (SPQ or RPQ or Placebo) daily for up to 5 days, with careful monitoring of hematological parameters before and after each dose. In addition to the general CMP14 safety criteria, any subject who displays a fractional hemoglobin drop of 15% below his/her baseline value, then drug administration will stop (e.g. for baseline Hgb of 14 g/dL, if there is at any point a decrease of 2.1 g/dL). Hematocrit will be similarly monitored, with proportional stop criteria. Elevation in total bilirubin to 2.0 mg/dL or greater will also be used as a stopping criterion. After stopping drug administration (5 days or whenever stop criteria are met), subjects will have a 3-week washout period, and the study repeated with the other enantiomer, and similarly with Placebo.

Conditions

G6PD Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

RPQ (-) enantiomer

Cohort 1 will receive 15mg of RPQ every day for 5 days. Cohort 2 will receive 22.5 mg of RPQ every day for five days.

Group Type: EXPERIMENTAL

RPQ

Intervention Type: DRUG

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

SPQ (+) enantiomer

Cohort 1 will receive 15mg of SPQ every day for 5 days. Cohort 2 will receive 22.5 mg of SPQ every day for five days.

Group Type: EXPERIMENTAL

SPQ

Intervention Type: DRUG

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Placebo

Cohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Interventions

RPQ

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Intervention Type: DRUG

SPQ

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Intervention Type: DRUG

Placebo

The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.

Intervention Type: DRUG

Other Intervention Names

R-(-) Enantiomer of Primiquine Phosphate; S-(+) Enantiomer of Primaquine Phosphate

Eligibility Criteria

Inclusion Criteria

• G6PD deficient, otherwise normal healthy adults aged 18 to 65

Exclusion Criteria

• Known history of liver, kidney or hematological disease (other than G6PD deficiency)
• Known history of cardiac disease, non-sinus rhythm arrhythmia or QT prolongation
• Autoimmune disorders
• Report of an active infection
• Subject is pregnant or breast-feeding, or is expecting to conceive during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Mississippi, Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Walker, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi

University, Mississippi, United States

Countries

United States

Other Identifiers

PQ Study 3

Identifier Type: -

Identifier Source: org_study_id