Pharmacokinetic Study of MIN-101 in Healthy Subjects

February 23, 2015 updated by: Minerva Neurosciences

A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites Following Single and Multiple Dose Modified Release Prototype Formulation Administration in Healthy Cytochrome P450 2D6 Extensive Metabolizer Male and Female Subjects, and to Evaluate the Relationship Between the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites and Cardiovascular Parameters.

The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ruddington, Nottingham, United Kingdom, NG116JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2
  • Must be CYP2D6 Extensive metabolizer
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception

Key Exclusion Criteria:

  • Subjects who have QTc > 430 in male, > 450 in female confirmed by a repeat ECG
  • Any family history of sudden cardiac death and Torsade de Points
  • No personal or family history of unexplained presyncope, syncope or orthostatic hypotension
  • History of any drug or alcohol abuse in the past 2 years
  • History or evidence of any medically diagnosed clinically significant psychiatric disorders
  • Suicidal tendencies or history of suicidal attempts
  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
  • Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
  • Positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: MIN-101

MIN-101

modified release formulation (MR),single oral dose between 16 and 64 mg
Drug: MIN-101
Experimental: Part 2: MIN-101 low dose

MIN-101

single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Drug: MIN-101
Placebo Comparator: Part 2: placebo

placebo MIN-101

daily oral dose from Day 1 to Day 7
Drug: Placebo
Experimental: Part 2: MIN-101 high dose

MIN-101

single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Drug: MIN-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio
Time Frame: predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)
Time Frame: predose to Day 8
predose to Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) -
Time Frame: from predose up to 72 h post dosing
from predose up to 72 h post dosing
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state
Time Frame: from predose up to 72 h post dosing
from predose up to 72 h post dosing
Part 2 Change from baseline in ECG parameters other than QT/QTc
Time Frame: from predose up to Day 8
QTcB, QRS, RR, PR intervals, U waves, T waves morphology
from predose up to Day 8
Part 2 Change from baseline in heart rate and blood pressure
Time Frame: from predose up to Day 8
from predose up to Day 8
Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose
Time Frame: from predose up to Day 8
from predose up to Day 8
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose
Time Frame: from predose up to Day 8
from predose up to Day 8
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)
Time Frame: from predose up to Day 8
from predose up to Day 8

Other Outcome Measures

Outcome Measure
Time Frame
Changes in sleep architecture and sleep continuity
Time Frame: Day 6
Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minerva Neurosciences

Investigators

  • Principal Investigator: Pui Leung, M.D, Quotient Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIN-101C02
  • 2014-001613-53 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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