Human Mass Balance Study of Pyronaridine (NCT01383109) | Clinical Trial Compass
CompletedPhase 1
Human Mass Balance Study of Pyronaridine
Switzerland6 participantsStarted 2011-06
Plain-language summary
The combination of pyronaridine and artesunate is an antimalarial therapy in development. This mass balance study is intended to determine the rate and extent of excretion of total radioactivity in urine and feces following administration of a single oral micro-dose of 14C-pyronaridine in humans.
Who can participate
Age range40 Years – 55 Years
SexMALE
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Inclusion criteria
✓. Male subjects between the ages of 40 and 55 years with a body weight between 60 and 90 kg and a body mass index calculated using Quetelet's Index - weight (kg)/height2 (m2) between 18.5 - 30.0
✓. Signed and dated written informed consent form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
✓. Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the investigator
✓. Strictly normal values of ALT, AST and bilirubin and normal or abnormal and clinically insignificant results (if agreed by the Investigator and the Sponsor on a case by case evaluation) of the other blood and urine laboratory parameters at screening
✓. All sexually active male subjects and their partners are willing to undergo contraception as follows:
✓. The ability to understand the requirements of the study and willingness to comply with all study procedures
Exclusion criteria
✕. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other clinical abnormality
✕. Known history of hypersensitivity, allergic or adverse reactions to Pyronaridine
✕. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
What they're measuring
1
Analysis of 14C-Pyronaridine Total Radioactivity in Urine
Timeframe: 2064 hours
2
Analysis of 14C-Pyronaridine Total Radioactivity in Feces
✕. Previous participation in any clinical study with Pyramax
✕. Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
✕. Known or suspected alcohol abuse or illicit drug use in the last 10 years before the study start or positive findings on urine drug screen
✕. Intake of grapefruit and grapefruit juice alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration