Safety, Tolerability, and PK Study of INE963 (QSC204132)
Research type
Research Study
Full title
A randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose and multiple dose study to assess the safety, tolerability, and pharmacokinetics of INE963 in healthy participants
IRAS ID
294378
Contact name
Cecile Hauschka
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000065-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 7 days
Research summary
The Sponsor, Novartis, is developing the test medicine INE963 for the potential treatment of malaria. The purpose of this study, CINE963A02101, is to assess the safety, tolerability, and pharmacokinetics (what the body does to the drug) of single ascending doses and multiple doses of INE963, when given orally in healthy male and female volunteers aged 18 to 55 years. Investigation of food effect will also be assessed.
The study will consist of up to two parts. It is planned that Part A will consist of four sequential groups where volunteers will be randomised to receive successively higher oral doses of INE963 or placebo (dummy test medicine). Groups A1, A2, and A4 (8 volunteers each) will be randomised in a 3:1 ratio to receive the test medicine or placebo. Volunteers in groups A3a and A3b will be randomised in a 4:1 ratio to receive INE963 or placebo without food (cohort A3a) and with food (cohort A3b). Groups A3a and A3b will involve the same 10 volunteers. An optional group A5 may also be included.
It is planned that Part B will consist of one group of 9 volunteers who will be randomised to receive oral doses of INE963 or placebo in a 2:1 ratio. An optional group B2 may also be included.
In Part A, volunteers will receive a single dose of the test medicine on Day 1 and will be discharged on Day 4. The volunteers will attend follow up visits on Days 6, 8, 9 and 12. In Part B, volunteers will be dosed on Days 1, 2 and 3 and will be discharged on Day 6. The volunteers will attend follow up visits on Day 8, 10, 11 and 14. An end of study visit will occur on Day 16 for Part A and Day 18 for Part B. All volunteers will have a follow up call approximately 30 days after their last dose.
REC name
HSC REC A
REC reference
21/NI/0049
Date of REC Opinion
29 Mar 2021
REC opinion
Favourable Opinion