Pharmacokinetic Study of MIN-101 in Healthy Subjects

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: MIN-101; Drug: Placebo

• Registration Number: NCT02232529
• Lead Sponsor: Minerva Neurosciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-05
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1: MIN-101	MIN-101	MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg
Part 2: placebo	Placebo	placebo MIN-101 daily oral dose from Day 1 to Day 7
Part 2: MIN-101 high dose	MIN-101	MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Part 2: MIN-101 low dose	MIN-101	MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7

Primary Outcome Measures

Name	Time	Method
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio	predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)	predose to Day 8

Secondary Outcome Measures

Name	Time	Method
Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) -	from predose up to 72 h post dosing
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state	from predose up to 72 h post dosing
Part 2 Change from baseline in ECG parameters other than QT/QTc	from predose up to Day 8	QTcB, QRS, RR, PR intervals, U waves, T waves morphology
Part 2 Change from baseline in heart rate and blood pressure	from predose up to Day 8
Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose	from predose up to Day 8
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose	from predose up to Day 8
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)	from predose up to Day 8

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington, Nottingham, United Kingdom