*DNDi-6899
Research type
Research Study
Full title
A Phase I Double-blind, placebo controlled (Part B only), randomised trial to evaluate the safety, tolerability and pharmacokinetics of single dose in fed state, and repeated doses of DNDI-6899 in healthy participants.
IRAS ID
1009683
Contact name
Saye Khoo
Contact email
Sponsor organisation
Drugs for Neglected Diseases intiative
ISRCTN Number
ISRCTN31974125
Research summary
DNDI-6899 is a new medicine being developed for the treatment of a disease called Visceral Leishmaniasis (VL), which is a disease caused by a parasite (an organism that lives in a host and gets its food at the expense of its host). It is common in areas such as East Africa, India and Brazil.
The trial will be done in 2 parts: Part A and B, with up to 36 participants in total.
Part A is to look at two single doses to test the effect of food on the absorption of the trial medicine into the body. Participants will undergo treatment in both fed and fasted states.
Part B is blinded and is to look at increasing the dose from one small group of participants to the next, to find a safe dose.
Part A:
Part A will consist of testing two single doses of IMP in two treatment periods: fed and fasted. After consent and eligiblity checks, participants will be admitted to the NIHR Clinical Research Facility (CRF) at the Liverpool University Hospitals NHS Trust twice for 6 days. Participants will take 500mg of DNDi-6899 under two treatment phases: both fed and fasted, of 6 days each. The first treatment phase will be determined by random allocation, followed by a 10 day washout period. Treatment will then commence under the opposite treatment allocation. Follow up will take place approximately 14-21 days after, with frequent blood tests and procedures to test safety. WOCBP will return for a final followup visit at 28 days.
Part B:
Part B will consist of up to 3 groups of participants with 8 in each group. Part B will be blinded (DNDi-6899 or placebo) so participants will not know which treatment they will receive. Part B will be to look at dose escalation of DNDi-6899, with safety meetings after each cohort to review safety data and give permission to dose escalate if the product is proved to be safe. Participants will be admitted to the CRF for 15 days with follow up 14-21 and 28 days (WOCBP only) after discharge from the CRF.
All partcipants will be reimbursed.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0121
Date of REC Opinion
28 Jun 2024
REC opinion
Further Information Favourable Opinion