Pharmacokinetic Study of MIN-101 in Healthy Subjects

NCT02232529 | Completed Phase 1

• 2 other identifiers: MIN-101C022014-001613-53
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

modified release formulation; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• 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

Other Outcomes (1)

• Changes in sleep architecture and sleep continuity

  Day 6

Study Arms (4)

Part 1: MIN-101

EXPERIMENTAL

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

Drug: MIN-101

Part 2: MIN-101 low dose

EXPERIMENTAL

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

Drug: MIN-101

Part 2: placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: MIN-101 high dose

EXPERIMENTAL

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

Drug: MIN-101

Interventions

MIN-101 DRUG

Part 1: MIN-101; Part 2: MIN-101 high dose; Part 2: MIN-101 low dose

Placebo DRUG

Part 2: placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minerva Neurosciences: lead

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG116JS, United Kingdom

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

roluperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Pui Leung, M.D

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

GB (1)