G6PD DeficiencyPhase 1NCT04073953
Primaquine Enantiomers in G6PD Deficient Human Volunteers
A Phase 1 study testing RPQ and SPQ in people with G6PD Deficiency, run by University of Mississippi, Oxford at 1 site in United States.
Trial summary
This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- G6PD Deficiency
- What is being tested?
- RPQ and SPQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- G6PD deficient, otherwise normal healthy adults aged 18 to 65
Who cannot join
- Known history of liver, kidney or hematological disease (other than G6PD deficiency)
- Known history of cardiac disease, non-sinus rhythm arrhythmia or QT prolongation
- Autoimmune disorders
- Report of an active infection
- Subject is pregnant or breast-feeding, or is expecting to conceive during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi
University, Mississippi, 38677
About this study
Official title: Metabolism and Pharmacokinetics of Primaquine Enantiomers in G6PD Deficient Human Volunteers Receiving a Five Day Dose Regimen
This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days.
Read the detailed description
Each subject will receive a 15 mg dose of one enantiomer (SPQ or RPQ or Placebo) daily for up to 5 days, with careful monitoring of hematological parameters before and after each dose. In addition to the general CMP14 safety criteria, any subject who displays a fractional hemoglobin drop of 15% below his/her baseline value, then drug administration will stop (e.g. for baseline Hgb of 14 g/dL, if there is at any point a decrease of 2.1 g/dL). Hematocrit will be similarly monitored, with proportional stop criteria. Elevation in total bilirubin to 2.0 mg/dL or greater will also be used as a stopping criterion. After stopping drug administration (5 days or whenever stop criteria are met), subjects will have a 3-week washout period, and the study repeated with the other enantiomer, and similarly with Placebo.
- Conditions
- G6PD Deficiency
- Being tested
- RPQ, SPQ, Placebo
- Keywords
- G6PD, Hemolysis, Primaquine, Pharmacokinetics, Malaria
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency, Hemolysis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPQDrug
Also called R-(-) Enantiomer of Primiquine Phosphate
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
SPQDrug
Also called S-(+) Enantiomer of Primaquine Phosphate
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
PlaceboDrug
The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
| Study group | Role | What they receive |
|---|---|---|
| RPQ (-) enantiomer | Experimental | 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. Receives: Drug: RPQ |
| SPQ (+) enantiomer | Experimental | 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. Receives: Drug: SPQ |
| Placebo | Placebo comparator | Cohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Methemoglobin concentration in blood from baseline
Change in Methemoglobin concentration in blood from baseline (% hemoglobin)
Measured: Days 0, 3, 5
Secondary outcomes (9)
Primaquine Plasma Concentration, ng/mL
Plasma concentrations of parent drug
Measured: Days 0, 3, 5
Carboxy-Primaquine Plasma Contration, ng/mL
Plasma concentrations of carboxy-primaquine metabolite
Measured: Days 0, 3, 5
Primaquine N-carbamoyl-glucuronide Plasma contration, ng/mL
Plasma concentrations of Primaquine N-carbamoyl-glucuronide metabolite
Measured: Days 0, 3, 5
Primaquine Orthoquinone Plasma concentration, ng/mL
Plasma concentrations of Primaquine Orthoquinone metabolite
Measured: Days 0, 3, 5
Change in Hematocrit (%) compared to baseline
Change in Hematocrit (%) compared to baseline
Measured: Days 0, 3, 5
Change in Hemoglobin (g/dL) compared to baseline
Change in Hemoglobin (g/dL) compared to baseline
Measured: Days 0, 3, 5
Change is AST (U/L) compared to baseline
Change is AST (U/L) compared to baseline; used to monitor liver function
Measured: Days 0, 3, 5
Change in ALT (U/L) compared to baseline
Change in ALT (U/L) compared to baseline; used to monitor liver function
Measured: Days 0, 3, 5
Change in total Bilirubin (mg/dL) compared to baseline
Change in total Bilirubin (mg/dL) compared to baseline; used to monitor liver function and red cell integrity
Measured: Days 0, 3, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi, Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Larry Walker, Ph.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073953
- Sponsor's protocol ID
- PQ Study 3
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2019
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Pharmacokinetics of Primaquine Enantiomers in G6PD Deficient Human Volunteers Receiving a Five Day Dose Regimen
- ClinicalTrials.gov ID
- NCT04073953
- Acronym / sponsor ID
- PQ Study 3
- Conditions
- G6PD Deficiency
- Keywords
- G6PD, Hemolysis, Primaquine, Pharmacokinetics, Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Mississippi, OxfordUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single center, prospective, cross-over phase 1 trial. Eighteen subjects will be enrolled in the study evaluating the metabolism, pharmacokinetic behavior and tolerability of primaquine enantiomers and placebo over the course of 5 days.
Detailed description
Each subject will receive a 15 mg dose of one enantiomer (SPQ or RPQ or Placebo) daily for up to 5 days, with careful monitoring of hematological parameters before and after each dose. In addition to the general CMP14 safety criteria, any subject who displays a fractional hemoglobin drop of 15% below his/her baseline value, then drug administration will stop (e.g. for baseline Hgb of 14 g/dL, if there is at any point a decrease of 2.1 g/dL). Hematocrit will be similarly monitored, with proportional stop criteria. Elevation in total bilirubin to 2.0 mg/dL or greater will also be used as a stopping criterion. After stopping drug administration (5 days or whenever stop criteria are met), subjects will have a 3-week washout period, and the study repeated with the other enantiomer, and similarly with Placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RPQ (-) enantiomer | Experimental | Drug: RPQCohort 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. |
| SPQ (+) enantiomer | Experimental | Drug: SPQCohort 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. |
| Placebo | Placebo comparator | Drug: PlaceboCohort 1 will receive placebo capsules every day for 5 days. Cohort 2 will receive placebo capsules every day for five days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- G6PD deficient, otherwise normal healthy adults aged 18 to 65
Key exclusion criteria (5 listed)
- Known history of liver, kidney or hematological disease (other than G6PD deficiency)
- Known history of cardiac disease, non-sinus rhythm arrhythmia or QT prolongation
- Autoimmune disorders
- Report of an active infection
- Subject is pregnant or breast-feeding, or is expecting to conceive during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPQAlso: R-(-) Enantiomer of Primiquine PhosphateThe study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo. | Drug | RPQ (-) enantiomer |
| SPQAlso: S-(+) Enantiomer of Primaquine PhosphateThe study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo. | Drug | SPQ (+) enantiomer |
| PlaceboThe study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo. | Drug | Placebo |
Primary outcome
Change in Methemoglobin concentration in blood from baseline
Time frame: Days 0, 3, 5
Change in Methemoglobin concentration in blood from baseline (% hemoglobin)
9 secondary outcomes
Primaquine Plasma Concentration, ng/mL
Time frame: Days 0, 3, 5
Carboxy-Primaquine Plasma Contration, ng/mL
Time frame: Days 0, 3, 5
Primaquine N-carbamoyl-glucuronide Plasma contration, ng/mL
Time frame: Days 0, 3, 5
Primaquine Orthoquinone Plasma concentration, ng/mL
Time frame: Days 0, 3, 5
Change in Hematocrit (%) compared to baseline
Time frame: Days 0, 3, 5
Change in Hemoglobin (g/dL) compared to baseline
Time frame: Days 0, 3, 5
Change is AST (U/L) compared to baseline
Time frame: Days 0, 3, 5
Change in ALT (U/L) compared to baseline
Time frame: Days 0, 3, 5
Change in total Bilirubin (mg/dL) compared to baseline
Time frame: Days 0, 3, 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Walker, Ph.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPQ and SPQ in people with G6PD Deficiency, run by University of Mississippi, Oxford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Methemoglobin concentration in blood from baseline (time frame: Days 0, 3, 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.