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NCT03637517 · ClinicalTrials.gov registry record · Phase 1

Malaria: Relative Bioavailability and Food Effect of DSM265

A Phase 1 study, sponsored by Medicines for Malaria Venture.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target

NCT03637517: Completed Phase 1 study, sponsored by Medicines for Malaria Venture.

NCT03637517 is a Phase 1 study that has completed, run by Medicines for Malaria Venture. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03637517, a Phase 1 study, has completed, sponsored by Medicines for Malaria Venture.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study 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.

Primary Outcome

Maximum observed DSM265 plasma concentration

Interventions

  • DRUG DSM265-TPGS 34% SDD, 400 mg fasted
  • DRUG DSM265-TPGS 34% SDD, 400 mg fed
  • DRUG DSM265 25% SDD, 400 mg fasted

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2018-10-03
Est. Completion 2018-11-19
Phase Phase 1
Medicines for Malaria Venture

4 total trials

What the finished NCT03637517 record still lists

NCT03637517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).

The record links to 0 conditions, and to 3 interventions - of which DSM265-TPGS 34% SDD, 400 mg fasted is the first listed.

NCT03637517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03637517 about?

NCT03637517 is a clinical study titled "Malaria: Relative Bioavailability and Food Effect of DSM265". 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.

What is the current status of trial NCT03637517?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2018-10-03. Estimated completion is 2018-11-19.

What interventions are being tested in trial NCT03637517?

The interventions under investigation include: DSM265-TPGS 34% SDD, 400 mg fasted (DRUG), DSM265-TPGS 34% SDD, 400 mg fed (DRUG), DSM265 25% SDD, 400 mg fasted (DRUG).

Who is sponsoring clinical trial NCT03637517?

This trial is sponsored by Medicines for Malaria Venture, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03637517's enrollment target sits among peer trials

42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03637517, the US trial registry maintained by the National Library of Medicine. NCT03637517 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.