NCT02750384

Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects

Detailed description

This is a randomized, open label, single dose, parallel group study consisting of 3 groups of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected for 480 hours after dosing. This study will compare the relative bioavailability of the oral DSM265 50% spray dried dispersion (SDD) granules with that of a reference 25% SDD powder for suspension formulation, and evaluate the effect of food on the DSM265 50% SDD granules

Conditions

• Healthy Volunteers
• Bioavailability

Interventions

Type	Name	Description
DRUG	DSM265 50% SDD granules	Single oral dose 400 mg
DRUG	DSM265 25% SDD powder for suspension	Single oral dose 400 mg

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-04-25
• Last updated: 2016-09-14

Locations

1 site across 1 country: United States