drugset
drugset / Trial / NCT03637517

Malaria: Relative Bioavailability and Food Effect of DSM265

NCT03637517 ↗

Phase 1 Completed 42 enrolled Medicines for Malaria Venture AbbVie · collab
RandomizedParallel-groupOpen-labelOther

Summary

Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.

Timeline

Start
2018-10-03
Primary completion
2018-11-19
Completion
2018-11-19

Outcome

Mixed primary results

registry Sum of squares 0.899 (90% CI 0.805 to 1.004); ANOVA NCT03637517 ↗

registry Sum of squares 1.175 (90% CI 1.051 to 1.312); ANOVA NCT03637517 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DSM265 Small molecule 400 mg Oral

Indications

No indication recorded.