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Pharmacokinetic Study of MIN-101 in Healthy Subjects

23. februar 2015 opdateret af: Minerva Neurosciences

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.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part 1: MIN-101

MIN-101

modified release formulation (MR),single oral dose between 16 and 64 mg
Medicin: MIN-101
Eksperimentel: Part 2: MIN-101 low dose

MIN-101

single daily oral dose, low dose MR formulation, from Day 1 to Day 7
Medicin: MIN-101
Placebo komparator: Part 2: placebo

placebo MIN-101

daily oral dose from Day 1 to Day 7
Medicin: Placebo
Eksperimentel: Part 2: MIN-101 high dose

MIN-101

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 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
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)
Tidsramme: predose to Day 8
predose to Day 8

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tidsramme
Changes in sleep architecture and sleep continuity
Tidsramme: Day 6
Day 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Minerva Neurosciences

Efterforskere

  • Ledende efterforsker: Pui Leung, M.D, Quotient Clinical

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

3. september 2014

Først indsendt, der opfyldte QC-kriterier

4. september 2014

Først opslået (Skøn)

5. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MIN-101C02
  • 2014-001613-53 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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