Safety and Pharmacokinetics Study of DM1157 to Treat Malaria

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.

Timeline

Start

2018-07-31

Primary completion

2019-09-06

Completion

2019-09-06

Outcome

Outcome not reported

Stopped: “There was toxicity in higher dose groups and a therapeutic dose level was not found in lower dose groups.”

Publications

• Balevic SJ, Raja SM, Randell R, Deye GA, Conrad T, Nakamura A, Peyton DH, Shotwell S, Liebman K, Cohen-Wolkowiez M, Guptill JT. Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions. Infect Dis Ther. 2022 Apr;11(2):841-852. doi: 10.1007/s40121-022-00605-z. Epub 2022 Feb 20.

Drugs

Indications