- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Zuidlaren, Nederland, 9471 GP
- PRA International (former Pharma Bio-Research)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment Arm 1A
mirabegron, poor metabolizers
|
muntlig
Andre navn:
|
|
Eksperimentell: Treatment Arm 1B
mirabegron, extensive metabolizers
|
muntlig
Andre navn:
|
|
Eksperimentell: Treatment Arm 2
mirabegron/metoprolol
|
muntlig
Andre navn:
oral
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetics of mirabegron assessed by plasma concentration
Tidsramme: Pre-dose until 72 hours after dosing
|
Primary outcome measure for Part 1
|
Pre-dose until 72 hours after dosing
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetics of metoprolol assessed by plasma concentration
Tidsramme: Pre-dose until 48 hours after dosing
|
Primary outcome measure for Part 2
|
Pre-dose until 48 hours after dosing
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Principal Investigator, Pharma Bio-Research Group B.V., Zuidlaren, The Netherlands
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Adrenerge beta-antagonister
- Adrenerge antagonister
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Antihypertensive midler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Urologiske midler
- Adrenerge agonister
- Adrenerge beta-agonister
- Sympatolytika
- Adrenerge beta-1-reseptorantagonister
- Adrenerge beta-3-reseptoragonister
- Metoprolol
- Mirabegron
Andre studie-ID-numre
- 178-CL-005
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