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- Klinische proef NCT01478490
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol
An Open Label, One-sequence, Parallel Study to Compare the Single Dose Pharmacokinetics of YM178 in Healthy Poor or Extensive Metabolisers for CYP2D6 and to Assess the Effect of Multiple Doses of YM178 on the Metabolism of the Model Substrate Metoprolol
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The study is an open label, single center study. All subjects are genotyped for CYP2D6 before the study. Genotype expression is confirmed by dextromethorphan phenotyping.
Part I: The pharmacokinetic profile of a single dose of YM178 is compared in 8 healthy male subjects genotyped and phenotyped as poor metaboliser (PM) for CYP2D6 and in 8 healthy male subjects genotyped and phenotyped as extensive metaboliser (EM) for CYP2D6.
Part II: The effect of YM178 on the model substrate of CYP2D6 metoprolol is evaluated, using a cross-over design, in 12 healthy male subjects genotyped and phenotyped as EM for CYP2D6.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Zuidlaren, Nederland, 9471 GP
- PRA International (former Pharma Bio-Research)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
For Part I:
- Subject genotyped and phenotyped for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
For Part II:
- Subject genotyped and phenotyped as extensive metaboliser for CYP2D6
- Body weight between 60 and 100 kg and Body Mass Index less than or equal to 30 kg/m2
Exclusion Criteria:
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
- Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- QTc intervals of >430 msec
- Abnormal pulse rate measurement (<40 or >90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min
- Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows: systolic blood pressure <95 or >160 mmHg; diastolic blood pressure <40 or >95 mmHg
- Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm
- Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Treatment Arm 1A
mirabegron, poor metabolizers
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oraal
Andere namen:
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Experimenteel: Treatment Arm 1B
mirabegron, extensive metabolizers
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oraal
Andere namen:
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Experimenteel: Treatment Arm 2
mirabegron/metoprolol
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oraal
Andere namen:
oral
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pharmacokinetics of mirabegron assessed by plasma concentration
Tijdsspanne: Pre-dose until 72 hours after dosing
|
Primary outcome measure for Part 1
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Pre-dose until 72 hours after dosing
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Pharmacokinetics of metoprolol assessed by plasma concentration
Tijdsspanne: Pre-dose until 48 hours after dosing
|
Primary outcome measure for Part 2
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Pre-dose until 48 hours after dosing
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Principal Investigator, Pharma Bio-Research Group B.V., Zuidlaren, The Netherlands
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Adrenerge beta-antagonisten
- Adrenerge antagonisten
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Middelen tegen aritmie
- Antihypertensiva
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Urologische middelen
- Adrenerge agonisten
- Adrenerge beta-agonisten
- Sympathicolytica
- Adrenerge bèta-1-receptorantagonisten
- Adrenerge bèta-3-receptoragonisten
- Metoprolol
- Mirabegron
Andere studie-ID-nummers
- 178-CL-005
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