Safety and Pharmacokinetics Study of DM1157 to Treat Malaria
Status:
Terminated
Trial end date:
2019-09-06
Target enrollment:
Participant gender:
Summary
This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple
ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in
healthy adults. The study will enroll 104 healthy volunteers, males and females, aged 18 to
45 years and will consists of 3 parts: Part 1, Single Ascending Dose (SAD); Part 2, Multiple
Ascending Dose (MAD); and Part 3, Food Effect. Part 2 and Part 3 may be initiated after a
Safety Monitoring Committee (SMC) review and approval of the of Part 1 safety data. Study
duration will be 16 months with patient participation duration 14 days for SAD and Food
Effect, and 18 days for MAD. The primary objectives of this study are to: 1) assess the
safety and tolerability of single doses of DM1157 at levels ranging from 9 mg to 900 mg; 2)
assess the safety and tolerability of DM1157 administered as single daily doses for 3 days at
levels ranging from 150 mg to 900 mg; 3) assess the safety and tolerability of DM1157
administered with or without food.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)