Pharmacokinetic Study of MIN-101 in Healthy Subjects

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Minerva Neurosciences

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