Pharmacokinetic Study of MIN-101 in Healthy Subjects

NCT ID: NCT02232529

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE

Study Groups

Part 1: MIN-101

MIN-101

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

Group Type: EXPERIMENTAL

MIN-101

Intervention Type: DRUG

Part 2: MIN-101 low dose

MIN-101

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

Group Type: EXPERIMENTAL

MIN-101

Intervention Type: DRUG

Part 2: placebo

placebo MIN-101

daily oral dose from Day 1 to Day 7

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Part 2: MIN-101 high dose

MIN-101

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

Group Type: EXPERIMENTAL

MIN-101

Intervention Type: DRUG

Interventions

MIN-101

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minerva Neurosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pui Leung, M.D

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Locations

Quotient Clinical

Ruddington, Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2014-001613-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MIN-101C02

Identifier Type: -

Identifier Source: org_study_id