NCT03929016 is a Phase 1 clinical trial of DNDI-0690 in Visceral Leishmaniasis, sponsored by Drugs for Neglected Diseases.

Who is sponsoring NCT03929016?

NCT03929016 is sponsored by Drugs for Neglected Diseases.

What drugs are being tested in NCT03929016?

Interventions in NCT03929016: DNDI-0690, Placebo of DNDI-0690.

What condition does NCT03929016 study?

NCT03929016 studies Visceral Leishmaniasis, Cutaneous Leishmaniases.

Is NCT03929016 still recruiting?

NCT03929016 is currently completed. Last updated 20 December 2022.

Last reviewed 2022-12-20 · How we verify

NCT03929016

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects

Completed Phase 1 Last updated 20 December 2022

What this trial tests

Phase 1 trial testing DNDI-0690 in Visceral Leishmaniasis in 64 participants. Completed in 2 July 2020.

Timeline

4 April 2019

Primary endpoint
6 December 2019

2 July 2020

Quick facts

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	4 April 2019
Primary completion	6 December 2019
Estimated completion	2 July 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

DNDI-0690 — full drug profile →
Placebo of DNDI-0690 — full drug profile →

Conditions studied

Visceral Leishmaniasis — all drugs for Visceral Leishmaniasis →
Cutaneous Leishmaniases — all drugs for Cutaneous Leishmaniases →

Sponsor

Drugs for Neglected Diseases — full company profile →

Who can join

Adults 18 to 60, any sex, with Visceral Leishmaniasis or Cutaneous Leishmaniases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the body and will also look at the safety and tolerability of the test medicine after a single dose. This is the first time the test medicine DNDI-0690 will be administered to humans.

Publications & conference data

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

Further Investigations of Nitroheterocyclic Compounds as Potential Antikinetoplastid Drug Candidates.
García-Estrada C, Pérez-Pertejo Y, Domínguez-Asenjo B, Holanda VN, et al · · 2023 · cited 10× · PMID 37189384 · DOI 10.3390/biom13040637
Trypanosomatid-Caused Conditions: State of the Art of Therapeutics and Potential Applications of Lipid-Based Nanocarriers.
Muraca G, Berti IR, Sbaraglini ML, Fávaro WJ, et al · · 2020 · cited 8× · PMID 33324615 · DOI 10.3389/fchem.2020.601151
Synthesis and biological evaluation of 4,7,9-trisubstituted benzoxazepines as antileishmanial agents.
Kadayat TM, Kwiatkowski S, Ortiz D, Shoeran G, et al · · 2024 · cited 3× · PMID 39477128 · DOI 10.1016/j.bmcl.2024.130003
Validated LC-MS/MS Method for Quantifying the Antiparasitic Nitroimidazole DNDI-0690 in Preclinical Target Site PK/PD Studies.
Schouten WM, van Bocxlaer K, Rosing H, Huitema ADR, et al · · 2025 · cited 1× · PMID 40568808 · DOI 10.1002/bmc.70158

Verify or expand the search:

Other recruiting trials for Visceral Leishmaniasis

Currently open trials in the same condition.

NCT05602610 — Clinical Prognostic Score to Predict Relapse in VL · recruiting
NCT04342715 — A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis · active not recruiting

Other Drugs for Neglected Diseases trials

Trials by the same sponsor.

NCT06997159 — A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefos · Phase 2 · not yet recruiting
NCT06512714 — Mycetoma Retrospective Data Collection · recruiting
NCT06356974 — Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) · Phase 3 · not yet recruiting
NCT05957978 — LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study · Phase 2 · completed
NCT05947604 — DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03929016 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Drugs for Neglected Diseases
Last refreshed: 20 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03929016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing