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Pharmacokinetic Study of MIN-101 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02232529
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Minerva Neurosciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: MIN-101 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: MIN-101

MIN-101

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

 Drug: MIN-101
Experimental: Part 2: MIN-101 low dose

MIN-101

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

 Drug: MIN-101
Placebo Comparator: Part 2: placebo

placebo MIN-101

daily oral dose from Day 1 to Day 7

 Drug: Placebo
Experimental: Part 2: MIN-101 high dose

MIN-101

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

 Drug: MIN-101


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
  2. Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF) [ Time Frame: predose to Day 8 ]

Secondary Outcome Measures :
  1. Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) - [ Time Frame: from predose up to 72 h post dosing ]
  2. Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state [ Time Frame: from predose up to 72 h post dosing ]
  3. Part 2 Change from baseline in ECG parameters other than QT/QTc [ Time Frame: from predose up to Day 8 ]
    QTcB, QRS, RR, PR intervals, U waves, T waves morphology

  4. Part 2 Change from baseline in heart rate and blood pressure [ Time Frame: from predose up to Day 8 ]
  5. Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose [ Time Frame: from predose up to Day 8 ]
  6. Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose [ Time Frame: from predose up to Day 8 ]
  7. Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests) [ Time Frame: from predose up to Day 8 ]

Other Outcome Measures:
  1. Changes in sleep architecture and sleep continuity [ Time Frame: Day 6 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232529


Locations
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United Kingdom
Quotient Clinical
Ruddington, Nottingham, United Kingdom, NG116JS
Sponsors and Collaborators
Minerva Neurosciences
Investigators
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Principal Investigator: Pui Leung, M.D Quotient Clinical
More Information
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Responsible Party: Minerva Neurosciences
ClinicalTrials.gov Identifier: NCT02232529    
Other Study ID Numbers: MIN-101C02
2014-001613-53 ( EudraCT Number )
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Minerva Neurosciences:
modified release formulation
pharmacokinetics
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders