Overview

Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers, Study 1

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Mississippi, Oxford
Treatments:
Primaquine
Criteria
Inclusion Criteria:

- Adults (18-60 years of age)

- Informed consent

- Healthy

Exclusion Criteria:

- Known history of liver, kidney or hematological disease;

- known history of cardiac disease, arrhythmia, QT prolongation;

- Autoimmune disorder;

- Report of an active infection;

- Evidence of G6PD deficiency