Pharmacokinetic Study of MIN-101 in Healthy Subjects

Minerva Neurosciences

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: MIN-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232529

2014-001613-53 (EudraCT Number)

MIN-101C02

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

32 participants in 4 patient groups, including a placebo group

Part 1: MIN-101

Experimental group

Description:

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

Treatment:

Drug: MIN-101

Part 2: MIN-101 low dose

Experimental group

Description:

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

Treatment:

Drug: MIN-101

Part 2: placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part 2: MIN-101 high dose

Experimental group

Description:

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

Treatment:

Drug: MIN-101