Trial | NCT02232529  Report issue

Title

Pharmacokinetic Study of MIN-101 in Healthy Subjects
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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
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 Started
Sep 30
2014
Primary Completion
Feb 28
2015
Study Completion
Feb 28
2015
Last Update
Feb 24
2015
Estimate

Drug MIN-101

Drug Placebo

Part 1: MIN-101 Experimental

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

Part 2: MIN-101 low dose Experimental

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

Part 2: placebo Placebo Comparator

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

Part 2: MIN-101 high dose Experimental

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

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
No Results Posted