NCT03637517

Malaria: Relative Bioavailability and Food Effect of DSM265

Completed Phase 1 Results posted Last updated 11 March 2020

What this trial tests

Phase 1 trial testing DSM265-TPGS 34% SDD, 400 mg fasted in Healthy Volunteers in 42 participants. Completed in 19 November 2018.

Timeline

3 October 2018

Primary endpoint
19 November 2018

19 November 2018

Quick facts

Lead sponsor	Medicines for Malaria Venture
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	42
Start date	3 October 2018
Primary completion	19 November 2018
Estimated completion	19 November 2018
Sites	1 location across United States

Drugs / interventions tested

• DSM265-TPGS 34% SDD, 400 mg fasted — full drug profile →
• DSM265-TPGS 34% SDD, 400 mg fed — full drug profile →
• DSM265 25% SDD, 400 mg fasted — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Medicines for Malaria Venture — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax Primary · 21 days

Maximum observed DSM265 plasma concentration

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	15300	± 27
DSM265-TPGS 34% SDD, 400 mg Fasted	14200	± 28
DSM265-TPGS 34% SDD, 400 mg Fed	11200	± 27

AUC168 Primary · 168 hours

Area under the plasma concentration-time curve from time 0 to 168 hours (AUC168)

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	1100000	± 14
DSM265-TPGS 34% SDD, 400 mg Fasted	987000	± 17
DSM265-TPGS 34% SDD, 400 mg Fed	1160000	± 22

AUCt Primary · 21 days

AUC from time 0 until the last measurable concentration (AUCt),

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	1750000	± 20
DSM265-TPGS 34% SDD, 400 mg Fasted	1570000	± 19
DSM265-TPGS 34% SDD, 400 mg Fed	1840000	± 20

Tmax Primary · 21 days

Time to Cmax.

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	2.4	± 1.4
DSM265-TPGS 34% SDD, 400 mg Fasted	2.1	± 0.9
DSM265-TPGS 34% SDD, 400 mg Fed	11.4	± 8.4

β Primary · 21 days

Apparent terminal phase elimination rate constant

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	0.00556	± 0.00189
DSM265-TPGS 34% SDD, 400 mg Fasted	0.00531	± 0.00154
DSM265-TPGS 34% SDD, 400 mg Fed	0.00595	± 0.00231

C168 Primary · 7 days

Plasma concentration at 168 hours

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	4090	± 25
DSM265-TPGS 34% SDD, 400 mg Fasted	3540	± 25
DSM265-TPGS 34% SDD, 400 mg Fed	4200	± 24

AUCinf Secondary · 21 days

AUC from time 0 to infinity (AUCinf)

Group	Value	95% CI
DSM265 25% SDD, 400 mg Fasted	1960000	± 29
DSM265-TPGS 34% SDD, 400 mg Fasted	1760000	± 26
DSM265-TPGS 34% SDD, 400 mg Fed	2040000	± 23

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamin E TPGS-Based Nanomedicine, Nanotheranostics, and Targeted Drug Delivery: Past, Present, and Future.
   Mehata AK, Setia A, Vikas, Malik AK, et al · · 2023 · cited 37× · PMID 36986583 · DOI 10.3390/pharmaceutics15030722
2. Scoping Review of Antimalarial Drug Candidates in Phase I and II Drug Development.
   Abd-Rahman AN, Zaloumis S, McCarthy JS, Simpson JA, et al · · 2022 · cited 15× · PMID 34843390 · DOI 10.1128/aac.01659-21
3. Evaluating the safety, pharmacokinetics, and antiparasitic activity of DSM265, a novel antimalarial plasmodium dihydroorotate dehydrogenase inhibitor: a systematic review and meta-analysis of early clinical trials.
   Sula I, Jihwaprani MC, Ahmad I, Khan TA, et al · · 2026 · cited 1× · PMID 41703549 · DOI 10.1186/s12936-026-05826-y