NCT03038646

A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects

A Phase 1, Open-Label, Randomised, 3-Treatment, 3-Period, Single-Dose, Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Properties of Modified Release (MR) Formulations of MIN-101 Followed by Food Effect Testing of a Selected Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Minerva Neurosciences · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

* To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects * To select 1 MR formulation for use in fed state * To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	MIN-101

Timeline

• Start date: 2016-11-30
• Primary completion: 2017-04-20
• Completion: 2017-04-20
• First posted: 2017-02-01
• Last updated: 2017-08-31

Locations

1 site across 1 country: Ireland