A study to evaluate safety and PK of DNDI-0690 in healthy volunteers

• Research type

  Research Study

• Full title

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

• IRAS ID

  288914

• Contact name

  Ezanul Wahab

• Contact email

  ezanul.wahab@simbecorion.com

• Sponsor organisation

  Drugs for Neglected Diseases initiative (DNDi)

• Eudract number

  2020-003963-24

• ISRCTN Number

  ISRCTN30122193

• Duration of Study in the UK

  0 years, 6 months, 14 days

• Research summary

  The purpose of this study is to investigate the study drug DNDI-0690.
  The main objectives are as follows:
  - To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of DNDI-0690 when it is administered as multiple doses at different dose strengths over a period of up to 10 days.

  - To investigate the concentration of DNDI-0690 in the blood and urine, how this changes over a period of time and whether there are differences in the concentration profile between different dose strengths.

  - To investigate whether DNDI-0690 has any effect on the function of the heart and kidneys.

  This study will be split into 3 separate parts: Part A, Part B and Part C.

  Part A will evaluate the objectives when DNDI-0690 is given at different dose strengths once or twice a day for 10 days. Part A will enrol 4 groups of 9 participants; each group investigating a different dose strength.

  Part B will evaluate the objectives when DNDI-0690 is given once a day for 5 days at a maximum dose strength of 3600 milligrams (mg). Part B will consist of 1 group of 9 participants investigating a dose strength higher than that which is intended to be given in order to treat the disease. This part is considered optional.

  Part C will evaluate the effect of DNDI-0690 on the function of the kidneys when it is given once a day for a period of 10 days. Part C will consist of 1 group of 9 participants investigating a dose strength considered to be the highest well tolerated dose from doses investigated in Part A.

  The study will be conducted in up to 54 healthy males and females (of non-childbearing potential).

• REC name

  Wales REC 1

• REC reference

  20/WA/0258

• Date of REC Opinion

  2 Nov 2020

• REC opinion

  Further Information Favourable Opinion