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A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers

NCT03072056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-08-31

No results posted yet for this study

Summary

* To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers
* To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals
* To evaluate safety and tolerability of MIN-101.

Conditions

  • Healthy Subjects

Interventions

DRUG

MIN-101

Sponsors & Collaborators

  • Minerva Neurosciences

    lead INDUSTRY

Principal Investigators

  • Daniel Jabbari, MD · BioKinetic Europe Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2017-07-07
Completion
2017-07-07

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 NCT03072056 on ClinicalTrials.gov