Safety, tolerability and PK study of DNDI-0690 (QSC200932)
Research type
Research Study
Full title
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 Male Subjects
IRAS ID
258564
Contact name
Sharan Sidhu
Contact email
Sponsor organisation
DNDi
Eudract number
2018-002021-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 11 days
Research summary
The Sponsor, Drugs for Neglected Diseases initiative (DNDi), is developing a new test medicine, DNDI-0690, for the potential treatment of Leishmaniasis.
Leishmaniasis is a tropical disease caused by Leishmania parasites and is spread by the bite of certain types of sandflies. Cases have been recorded in 101 countries around the world and there are 350 million people at risk of getting the disease. Symptoms of the disease can range from skin ulcers, fever, and weight loss and can be fatal if left untreated. Current treatment options are limited, can be toxic and require long hospitalisations. DNDI-0690 is being developed as a safe, effective, oral, short-course treatment for patients.
This study will look at the safety and tolerability of the test medicine, as well as the level of test medicine present in blood and urine after single oral doses.
The study will consist of up to 8 sequential dose cohorts involving up to 64 healthy male volunteers (8 volunteers per cohort). Each cohort will be split into 2 sub-cohorts, with sentinel dosing of 2 volunteers (1 volunteer receiving the test medicine, 1 volunteer receiving a dummy medicine (placebo)) followed by a second dosing of 6 volunteers (5 receiving the test medicine, 1 receiving placebo). In Cohort 1, volunteers will be randomly assigned to receive a single dose 10 mg capsule of DNDI-0690 or placebo (dummy medicine) to swallow. Dose levels for subsequent cohorts will be decided based on emerging safety and PK data, with a minimum of 7 days between each cohort.
Volunteers will remain in the clinical unit until 72 hours post dose. A follow-up visit will take place 7 to 10 days post-dose to ensure the ongoing wellbeing of the volunteer.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0373
Date of REC Opinion
14 Mar 2019
REC opinion
Further Information Favourable Opinion