The purpose of the study is to understand whether the drug praziquantel (PZQ) is metabolized
or broken down differently when women are pregnant versus not pregnant. PZQ is used to treat
schistosomiasis (worm infection). Researchers will study how PZQ is broken down among 15
women who are 12-16 weeks pregnant, 15 women who are 30-36 weeks pregnant, and 15 women
nonpregnant women who are producing breast milk. All women will be 18 or older and otherwise
healthy. The usual practice is to wait until after mothers have finished pregnancy and breast
feeding before giving PZQ. Participants will receive 2 doses of PZQ separated by 3 hours.
Study procedures will include a 24 hour hospital stay following administration of PZQ, blood,
stool and urine samples, ultrasound if pregnant, and physical exams of mother and baby.
Patient participation for mother/infant pair is about 9 months.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)