Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT02960568
Eligibility Criteria:
Inclusion criteria:
* Active duty Service member, (male or female) 18 to 60 years of age (inclusive) at the time of enrollment
* Written informed consent for phase 1 must be obtained
* Written informed consent for phase 2 must be obtained from the subject before the screening procedures
* Free of significant health problems as established by medical history, laboratory and clinical examination before entering the study
* If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of the administration of primaquine , and must agree to continue such precautions until 48 hours after primaquine administration.
* Normal (non-deficient) G6PD (glucose-6-phosphate dehydrogenase) phenotype (range: 4.6 to 13.5 units/gm hemoglobin)
* Subjects must obtain approval from his or her supervisor per Walter Reed Army Institute of Research (WRAIR) Policy 06-15 in order to be participate in the PQ PK portion of phase 2
Exclusion criteria:
* Use of any investigational or non-registered drug within 30 days preceding the primaquine dosing.
* Pregnant (positive urine β-HCG) or nursing at screening or plans to become pregnant or nurse from the time of enrollment until 48 hours after primaquine dosing.
* Allergy to primaquine
* Use of medications known to cause drug interactions with primaquine or CYP2D6
* Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurologic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation
* History of hemolytic anemia
* Any abnormal baseline laboratory screening tests listed below (normal values are defined by the current Quest Diagnostics reference guide on file in the CTC):
* ALT (alanine aminotransferase)above normal range
* Glomerular filtration rate (GFR) below normal range for the subject's ethnicity
* Hemoglobin below normal range
* Hepatomegaly, right upper quadrant abdominal pain or tenderness
* Suspected or known current alcohol abuse as determined from the medical history or by physical examination
* Use of any drugs that may cause hemolytic anemia and/or bone marrow suppression such as quinacrine, dapsone, rifampin, colchicine, ribavirin, penicillamine and sulfonamides.
* Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02960568
Study Brief:
Protocol Section:
NCT02960568