PK comparison of 3 MR formulations of MIN-101 & food effect in one MR
Research type
Research Study
Full title
A Phase 1, Open-Label, Randomised, 3-Treatment Sequence, 3-Period, Single-Dose, Crossover Study in CYP2D6 Extensive Metaboliser Healthy Subjects to Compare the Pharmacokinetic Properties of 2 Gastro-Resistant and 1 Comparator Modified Release Formulations of MIN‑101 and its Metabolites Followed by Food Effect Testing of the Selected Gastro-Resistant Modified Release Formulation.
IRAS ID
217636
Contact name
Joseph Reilly
Contact email
Sponsor organisation
Minerva Neurosciences, Inc.
Eudract number
2016-004285-26
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
This is a single-centre, 2-part phase 1 study in MIN-101, an investigational drug being developed as a potential treatment for schizophrenia.
Part 1 is an open-label, randomised, 3-treatment sequence, 3-period study to evaluate the PK profile of MIN-101 and its metabolites (BFB-520 and BFB-999) after single oral administration of 3 formulations of MIN-101 (2 prototypes of MR gastro-resistant (GR) formulations and 1 comparator MR formulation). Each volunteer will receive a single dose of each of the formulations over the 3 periods. There will be a washout of 14 +/- 2 days between the three periods.
In total, 16 healthy CYPD26 EM male or female subjects (with an equal gender split, but a minimum of 6 of each sex) will be dosed to ensure data in 12 evaluable subjects.
Part 2: Part 2 is a Food effect study.
Subjects who complete part 1 of the study will return and receive a further single oral dose of one of the selected MR prototypes under fed conditions to allow the assessment of food effect by comparison of the PK properties to those obtained in Part 1. Part 2 will commence after review of the PK and safety data to decide which MR formulation will be used. There will be a washout period of 14 +/- 2 days after part 1 has completed.
The end of study will be performed between 5-9 days after the last dose administration.
The total duration for both study periods will be a maximum of 78 days including the 21 day screening period.
REC name
HSC REC B
REC reference
16/NI/0238
Date of REC Opinion
16 Nov 2016
REC opinion
Favourable Opinion