- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668433
Pharmacokinetic and in Vitro Transmission Blocking Activities Study of Primaquine Compare to Methylene Blue in Healthy Volunteer Both G6PD Normal and G6PD Deficiency
Open Label Randomized Controlled Trial Pharmacokinetic and Vitro Transmission Blocking Activities Study of Primaquine Compare to Methylene Blue in Healthy Volunteer Both G6PD Normal and G6PD Deficiency
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 10400
- Hospital for Tropical Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For G6PD normal group, healthy males and females as judged by a physician with no abnormality identified on a medical evaluation including medical history and physical examination with laboratory diagnosis of G6PD normal.
For G6PD deficient group, healthy males with laboratory diagnosis of G6PD deficiency grade 3 with enzyme activity 10-60%.
- Subjects aged between 18 years to 60 years.
- Subjects who have Hb ≥ 11 mg/dl.
A female is eligible to enter and participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- or of childbearing potential, has a negative serum pregnancy test at screening and urine pregnancy test prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures.
- Read, comprehend, and write at a sufficient level to complete study-related materials.
- Provide a signed and dated written informed consent prior to study participation.
- Normal electrocardiogram (ECG) with QTc < 450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
Exclusion Criteria:
- Females who are pregnant, trying to get pregnant, or are lactating.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of hypertension, cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia).
- Subjects with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation: CLcr (mL/min) = (140 - age) * Wt / (72 * Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].
- History of alcohol or substance abuse or dependence within 6 months of the study: History of regular alcohol consumption averaging >7 drinks/wk for women or >14 drinks/wk for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits within 6 months of screening.
- Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
- The subject is unwilling to abstain from the ingestion of grapefruit containing products for 72 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each period.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.
- Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- AST or ALT >1.5 upper limit of normal (ULN).
- Subjects with history of renal disease, hepatic disease, and/or cholecystectomy.
- Abnormal methaemoglobin level.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: G6PD Normal
Subjects will be given either primaquine, 45 mg single dose or methylene blue, 600 mg single dose with a washout period of 7 days then followed by either methylene blue, 600 mg single dose or primaquine, 45 mg single dose.
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Primaquine 45 mg single dose Or Methylene Blue 600 mg single dose followed by Methylene Blue 600 mg single dose or Primaquine 45 mg single dose.
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Experimental: G6PD deficiency
Subjects will be given either primaquine, 45 mg single dose or methylene blue, 600 mg single dose with a washout period of 7 days then followed by either methylene blue, 600 mg single dose or primaquine, 45 mg single dose.
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Primaquine 45 mg single dose Or Methylene Blue 600 mg single dose followed by Methylene Blue 600 mg single dose or Primaquine 45 mg single dose.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile of Primaquine
Time Frame: 7 days
|
Maximum concentration (Cmax), Area under the concentration curve (AUC 0-24), Elimination rate constant (PRQ-λz), and Elimination half life (t1/2) for primaquine when given standard dose in G6PD normal and G6PD deficiency
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7 days
|
Pharmacokinetic profile of Carboxyprimaquine
Time Frame: 7 days
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Maximum concentration (Cmax), area under the concentration curve (AUC 0-24), elimination rate constant (PRQ-λz), and elimination half life (t1/2) for carboxyprimaquine (primaquine metabolite) when given standard dose in G6PD normal and G6PD deficiency
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7 days
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Pharmacokinetic profile of Methylene blue
Time Frame: 7 days
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Maximum concentration(Cmax), area under the concentration curve (AUC 0-24) elimination rate constant (MB-λz), and elimination half life (t1/2) for methylene blue when given standard dose in G6PD normal and G6PD deficiency
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7 days
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Oocysts production in mosquitoes
Time Frame: 7 days
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Reduction of oocysts production in mosquitoes fed with gametocytes which were exposed to methylene blue and primaquine
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7 days
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Methaemoglobin, Hematocrit and Hemoglobin levels
Time Frame: 7 days
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Methaemoglobin, hematocrit and hemoglobin level when given primaquine and methylene blue in G6PD normal and G6PD deficiency
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Primaquine and Methylene Blue
Time Frame: 1 month
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Safety and tolerability parameters, including adverse events, clinical laboratory, and vital signs assessments
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1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Glucosephosphate Dehydrogenase Deficiency
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Primaquine
- Methylene Blue
Other Study ID Numbers
- FTM1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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