Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen
NCT ID: NCT03934450
Last Updated: 2019-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2018-08-17
2019-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
Placebo will be added in order to assess tolerability of enantiomers. Placebo control is needed in non-drug related clinical responses.
BASIC_SCIENCE
SINGLE
Study Groups
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RPQ (-) enantiomer
Cohort 1 will receive 15 mg of RPQ (3A) every day for 7 days Cohort 2 will receive 22.5 mg of RPQ (3A) every day for 7 days
RPQ
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
SPQ (+) enantiomer
Cohort 1 will receive 15 mg of SPQ (2A) every day for 7 days Cohort 2 will receive 22.5 mg of SPQ (2A) every day for 7 days
SPQ
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Primaquine Phosphate
Cohort 1 will receive 30 mg of RSPQ (1A) every day for 7 days Cohort 2 will receive 45 mg of RSPQ (1A) every day for 7 days
Primaquine Phosphate
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Placebo
Cohort 1 will receive placebo (4A) capsules everyday for seven days Cohort 2 will receive placebo (4A) capsules everyday for seven days
Placebo
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Interventions
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RPQ
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
SPQ
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Primaquine Phosphate
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Placebo
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known history of cardiac disease, Non Sinus Rhythm arrhythmia or QT prolongation
* Autoimmune disorders
* Report of an active infection
* Evidence of G6PD deficiency
* Participant is pregnant or breast-feeding, or is expecting to conceive during the study.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Mississippi, Oxford
OTHER
Responsible Party
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Principal Investigators
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Larry Walker, Phd
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
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University of Mississippi
University, Mississippi, United States
Countries
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Other Identifiers
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PQ Study 2
Identifier Type: -
Identifier Source: org_study_id
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