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

NCT03038646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-31

No results posted yet for this study

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

DRUG

MIN-101

Sponsors & Collaborators

  • Minerva Neurosciences

    lead INDUSTRY

Principal Investigators

  • Daniel Jabbari, MD · BioKinetic Europe Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-04-20
Completion
2017-04-20

Countries

  • Ireland

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038646 on ClinicalTrials.gov