NCT03934450|CompletedPhase 1DMCFDA Drug
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Sponsor study identifier
interventional
36
1 country
1
Study Start
August 17, 2018
Actual (reported)Primary Completion
May 1, 2019
Actual (reported)Study Completion
May 1, 2019
Actual (reported)To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7 days.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2018
Actual (reported)August 17, 2018
Actual (reported)May 1, 2019
Actual (reported)May 1, 2019
Actual (reported)May 1, 2019
Actual (reported)Change in Methemoglobin concentration in blood from baseline
Change in Methemoglobin concentration in blood from baseline (% hemoglobin)
Days 0, 3, 5, 7
Primaquine Plasma concentration, ng/mL
Days 0, 3, 5, 7
Carboxy- Primaquine Plasma concentration, ng/mL
Days 0, 3, 5, 7
Primaquine N-carbamoyl-glucuronide Plasma concentration, ng/mL
Days 0, 3, 5, 7
Primaquine Orthoquinone Plasma concentration, ng/mL
Days 0, 3, 5, 7
Change in Hematocrit (%) Compared to baseline
Days 0, 3, 5, 7
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
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
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
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
University of Mississippi
University, Mississippi, 38677, United States
Larry Walker, Phd
University of Mississippi Medical Center
36 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2018
First Posted
May 1, 2019
Dose Escalation PfSPZ-CVac
Cohort 1 will receive placebo (4A) capsules everyday for seven days Cohort 2 will receive placebo (4A) capsules everyday for seven days
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
August 17, 2018
Actual (reported)Primary Completion
May 1, 2019
Actual (reported)Study Completion
May 1, 2019
Actual (reported)Last Updated
May 14, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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