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Completed

NCT Number: NCT02232529

Pharmacokinetic Study of MIN-101 in Healthy Subjects

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Ruddington, Nottingham, NG116JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIN-101

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  1. Changes in sleep architecture and sleep continuity

    Time frame: Day 6

Sponsors and collaborators

Lead sponsor

Minerva Neurosciences

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 5, 2014
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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