CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
DSM265-TPGS 34% SDD, 400 mg fasted +2 moredrug
Likely dose
DSM265-TPGS 34% SDD, 400 mg fastedfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03637517
NCT03637517Phase 1Completed
CompareCT.gov

Relative Bioavailability and Effect of Food on DSM265-TPGS 34% SDD Powder in Healthy Adult Subjects

Medicines for Malaria Venture·interventional·Posted Aug 20, 2018·Updated Mar 11, 2020

In Brief

A Phase 1 clinical trial evaluating DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed, and 1 other intervention for Healthy Volunteers. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsAbbVie

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 20, 2018
Enrollment StartOct 3, 2018
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.9 years ago

Interventions

DSM265-TPGS 34% SDD, 400 mg fasteddrug

New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state.

DSM265-TPGS 34% SDD, 400 mg feddrug

New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state.

DSM265 25% SDD, 400 mg fasteddrug

Reference formulation used in early clinical trials.