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Malaria: Relative Bioavailability and Food Effect of DSM265

NCT03637517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-03-11

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Joerg Moehrle, Ass Prof · Medicines for Malaria Venture

  • David Carter, MD · AbbVie Clinical Pharmacology Research Unit (ACPRU)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2018-11-19
Completion
2018-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03637517 on ClinicalTrials.gov