SAD ethnobridging 3-period trial evaluating safety and PK of SAR443820
Research type
Research Study
Full title
A Phase 1, open-label, 3-treatment period, 1-sequence, cross-over study of the pharmacokinetics, safety and tolerability after single ascending oral doses of SAR443820 in healthy adult Chinese and Japanese female and male participants.
IRAS ID
299749
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2021-001076-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 27 days
Research summary
This is an open-label cross-over study with 3 treatment periods in healthy adult Chinese and Japanese male and female participants performed at a single centre. Approximately 16 subjects aged 20 to 55 years will be included.\n\nThe main purpose of the clinical study is to evaluate the pharmacokinetics (amount of drug in the body over time), safety and tolerability of single oral (intake via mouth) ascending doses of SAR443820 in healthy adult East Asian participants to support the development of this new drug in East Asia. In addition, a blood sample for deoxyribonucleic acid (DNA, heredity information) analysis will be collected from participants since genetic variation may impact a participant’s response to study intervention. \n\nEach participant will receive 3 single oral doses of SAR443820 in the same sequence (order), with 1 dose each on Day 1 of 3 treatment periods: \n\nTreatment Period 1: 10 mg\nTreatment Period 2: 20 mg\nTreatment Period 3: 30 mg\n\nThere will be 2 groups, one comprising 8 Chinese and the other one 8 Japanese participants. Both groups will be dosed in parallel.\n\nThe single doses within the different treatment periods will be separated by at least 5 days without dosing (washout period). The study duration for each participant will be approximately 7 weeks. The study consists of a Screening Period of up to 4 weeks, 3 in-house periods of 4 days each (separated by at least 5 days between each dosing), and an End-of-study visit.\n\nSAR443820 is a novel compound being developed for the potential treatment of different chronic (of long duration) diseases of the central nervous system.\n\nThis is not a first-in-human study as the study drug has already been given to healthy adult subjects as single oral doses of 10 mg to 40 mg.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0373
Date of REC Opinion
29 Jun 2021
REC opinion
Further Information Favourable Opinion