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Antimalarial

RPQ for G6PD Deficiency

Phase 1
Waitlist Available
Led By Larry Walker, Ph.D.
Research Sponsored by University of Mississippi, Oxford
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
G6PD deficient, otherwise normal healthy adults aged 18 to 65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 3, 5
Awards & highlights

Study Summary

This trial will study the effects of primaquine enantiomers (a medication used to treat malaria) on metabolism, how the body processes the drug, and tolerability. 18 subjects will be enrolled and will take the medication for 5 days.

Eligible Conditions
  • G6PD Deficiency

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 3, 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 3, 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Methemoglobin concentration in blood from baseline
Secondary outcome measures
Carboxy-Primaquine Plasma Contration, ng/mL
Change in ALT (U/L) compared to baseline
Change in Hematocrit (%) compared to baseline
+6 more

Side effects data

From 2016 Phase 3 trial • 251 Patients • NCT02216123
22%
Pruritus
19%
Headache
19%
Dizziness
13%
Myalgia
11%
Urinary tract infection
9%
Vomiting
8%
Nausea
7%
Pyrexia
7%
Pharyngitis
6%
Asthenia
6%
Nasopharyngitis
4%
Back pain
4%
Diarrhoea
1%
Haemoglobin decreased
1%
Abdominal pain upper
100%
80%
60%
40%
20%
0%
Study treatment Arm
PQ+CQ
TQ+CQ

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SPQ (+) enantiomerExperimental Treatment1 Intervention
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 II: RPQ (-) enantiomerExperimental Treatment1 Intervention
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 III: PlaceboPlacebo Group1 Intervention
Cohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPQ
2018
Completed Phase 1
~40
Primaquine
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Southern Research InstituteUNKNOWN
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,530 Total Patients Enrolled
University of Mississippi, OxfordLead Sponsor
11 Previous Clinical Trials
974 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Primaquine Enantiomers in G6PD Deficient Human Volunteers
2020. "Primaquine Enantiomers in G6PD Deficient Human Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073953.
~4 spots leftby Apr 2025
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