SAD PK Comparison Study of MIN-101 in Poor and Extensive Metabolisers
Research type
Research Study
Full title
A Phase 1, Open-Label, 3-Period, Single-Ascending Dose, Crossover Study in Healthy Subjects to Compare the MIN-101 Pharmacokinetic Properties in Poor and Extensive Metabolizers as Defined by Cytochrome P450 2D6 Genotype.
IRAS ID
216634
Contact name
Joseph Reilly
Contact email
Sponsor organisation
Minerva Neurosciences, Inc.
Eudract number
2016-004014-98
Duration of Study in the UK
0 years, 3 months, 27 days
Research summary
This is a phase 1, open-label, 3-period, crossover, single-ascending dose study of MIN-101 administered as an oral solution. MIN-101 is an investigational drug being developed for the potential treatment of schizophrenia.
A total of 32 eligible healthy male and female volunteers aged 18 to 45 who are poor metabolizers (PM) or extensive metabolizers (EM) for cytochrome P450 2D6 will be enrolled to ensure that at least 12 volunteers of each group complete the planned dosing cohorts following a 21-day screening period.
Three single ascending doses of the study drug MIN-101 are planned per genotype cohort.
Volunteers will receive MIN-101 4 mg in period 1. Following review of the 4 mg dose safety and PK data, a single dose of 8 mg will be administered to the same cohort of subjects in period 2. This process will be repeated after review of the 8 mg to determine if the single 16 mg dose may be administered in period 3 to the same cohort of subjects.
Each administration will be separated by 14 days and up to 24 days to allow for review of PK and safety data.
The study consists of
- a screening phase - up to 21 days prior to study drug administration
- an open-label treatment phase consisting of up to 3 single-dose treatment periods - periods 1 to 3.
- a washout period of 14 to 24 days between periods for PK and safety assessments.
- end of study assessments within 12 ± 2 days of dosing in period 3.The duration of participation in the study for each individual will be approximately 77 to 81 days (including screening and end of study visit).
REC name
HSC REC A
REC reference
16/NI/0218
Date of REC Opinion
1 Nov 2016
REC opinion
Further Information Favourable Opinion