search
Back to results

Pharmacokinetic Study of MIN-101 in Healthy Subjects

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MIN-101
Placebo
Sponsored by
Minerva Neurosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring modified release formulation, pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: MIN-101

Part 2: MIN-101 low dose

Part 2: placebo

Part 2: MIN-101 high dose

Arm Description

MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg

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

placebo MIN-101 daily oral dose from Day 1 to Day 7

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

Outcomes

Primary Outcome Measures

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
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2014
Last Updated
February 23, 2015
Sponsor
Minerva Neurosciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02232529
Brief Title
Pharmacokinetic Study of MIN-101 in Healthy Subjects
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minerva Neurosciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
modified release formulation, pharmacokinetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: MIN-101
Arm Type
Experimental
Arm Description
MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg
Arm Title
Part 2: MIN-101 low dose
Arm Type
Experimental
Arm Description
MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Arm Title
Part 2: placebo
Arm Type
Placebo Comparator
Arm Description
placebo MIN-101 daily oral dose from Day 1 to Day 7
Arm Title
Part 2: MIN-101 high dose
Arm Type
Experimental
Arm Description
MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Intervention Type
Drug
Intervention Name(s)
MIN-101
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state
Time Frame
from predose up to 72 h post dosing
Title
Part 2 Change from baseline in ECG parameters other than QT/QTc
Description
QTcB, QRS, RR, PR intervals, U waves, T waves morphology
Time Frame
from predose up to Day 8
Title
Part 2 Change from baseline in heart rate and blood pressure
Time Frame
from predose up to Day 8
Title
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
Title
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose
Time Frame
from predose up to Day 8
Title
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)
Time Frame
from predose up to Day 8
Other Pre-specified Outcome Measures:
Title
Changes in sleep architecture and sleep continuity
Time Frame
Day 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pui Leung, M.D
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Ruddington, Nottingham
ZIP/Postal Code
NG116JS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Study of MIN-101 in Healthy Subjects

We'll reach out to this number within 24 hrs