CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Primaquine, R-Primaquine, S-Primaquine, SR Primaquinedrug
Likely dose
Primaquine, R-Primaquine, S-Primaquine, SR Primaquine 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02898779
NCT02898779Phase 1Completed
CompareCT.gov

Development of Safer Drugs for Malaria in U.S. Troops, Civilian Personnel, and Travelers: Clinical Evaluation of Primaquine Enantiomer

University of Mississippi, Oxford·interventional·Posted Sep 13, 2016·Updated May 15, 2018

In Brief

A Phase 1 clinical trial evaluating Primaquine, R-Primaquine, S-Primaquine, SR Primaquine for Malaria. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 13, 2016
Enrollment StartMay 1, 2017
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.8 years ago

Interventions

Primaquine, R-Primaquine, S-Primaquine, SR Primaquinedrug

Cohort 1: Eighteen individuals (6 per group) Cohort 2: Eighteen individuals (6 per group) Group 1-15 mg of S-Primaquine followed by one-week washout, 15 mg of R-Primaquine followed by one week washout, and 30 mg of RS-Primaquine. Group 2- 15 mg of R-Primaquine followed by one-week washout, 30 mg of RSPQ followed by one week washout, and 15 mg of SPQ. Group 3- 30 mg of RS-Primaquine followed by one week washout,15 mg of SPQ followed by a one week washout, and 15 mg of RPQ.