Status:
COMPLETED
Pharmacokinetic Study of MIN-101 in Healthy Subjects
Lead Sponsor:
Minerva Neurosciences
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02232529
Start Date
September 1 2014
End Date
February 1 2015
Last Update
February 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical
Ruddington, Nottingham, United Kingdom, NG116JS