NCT03637517

Malaria: Relative Bioavailability and Food Effect of DSM265

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective of this study is to compare the relative bioavailability of oral DSM265-TPGS 34% SDD formulation with that of a reference 25% SDD powder for suspension used in previous clinical trials. Another objective of the study is to evaluate the effect of food on bioavailability of the DSM265-TPGS 34% SDD formulation. The current 25% SDD powder for suspension clinical formulation is a suspension which requires reconstitution/administration in 240 mL sucralose based vehicle (for a 400 mg adult dose). This volume is too large for paediatric patients with malaria (e.g., translates into a 30 mL volume for 0.5-2 yr old patients); also, the dosing vehicle is not commercially viable. The new formulation dissolves in a smaller volume of a more common vehicle, water (40 mL for 400 mg adult dose).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DSM265-TPGS 34% SDD, 400 mg fasted	New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state.
DRUG	DSM265-TPGS 34% SDD, 400 mg fed	New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state.
DRUG	DSM265 25% SDD, 400 mg fasted	Reference formulation used in early clinical trials.

Timeline

• Start date: 2018-10-03
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2018-08-20
• Last updated: 2020-03-11
• Results posted: 2020-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study