NCT03929016

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

A Phase I, Double-blind, Randomised, Single Centre, Parallel Group, Single-dose, Dose-escalation, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of DNDI-0690 After Oral Dosing in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

DNDI-0690 is intended to be used as oral treatment for Visceral Leishmaniasis with potential for the cutaneous form of the disease, Cutaneous Leishmaniasis. The present protocol describes the first-in-human (FIH) study with DNDI-0690.

Conditions

• Visceral Leishmaniasis
• Cutaneous Leishmaniases

Interventions

Type	Name	Description
DRUG	DNDI-0690	capsules of 10, 100 and 200 mg
DRUG	Placebo of DNDI-0690	capsules of matching placebo

Timeline

• Start date: 2019-04-04
• Primary completion: 2019-12-06
• Completion: 2020-07-02
• First posted: 2019-04-26
• Last updated: 2022-12-20

Locations

1 site across 1 country: United Kingdom