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- Essai clinique NCT00940121
Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron
A Phase 1, Open-Label, Randomized, Parallel Dose Group Study to Assess the Pharmacokinetics of Mirabegron OCAS Formulations With Different Release Rates Versus IV Infusion in Healthy Volunteers
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Subjects will be randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of three oral mirabegron doses and then randomly assigned to one of six treatment sequences.
For all subjects the first treatment will be a reference IV dose. Treatments 2, 3, and 4 will be a random order of slow, fast and target release oral doses of mirabegron. Treatment 5 will be a target release dose of mirabegron from a different batch.
There will be at least 10 day washout between dose administrations.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Washington
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Tacoma, Washington, États-Unis, 98418
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2
- The subject must have a normal or clinically nonsignificant 12 lead ECG as well as normal or clinically non-significant laboratory test results
- Female subjects must be post-menopausal (defined as at least 2 years without menses) surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and should have a negative pregnancy test result
- The subject must have negative test results for drugs of abuse and alcohol screens
- The subject must have a good venous access in both arms
Exclusion Criteria:
- The subject has evidence of QTc interval >430 msec for male, >450 msec for female
- The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
- The subject has a history or presence of psychiatric illness, serious active or recurrent infection
- The subject has a previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years
- The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
- The subject has received or is anticipated to receive a prescription drug within 14 days (within 30 days for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
- The subject has consumed alcohol, xanthine derivative-containing beverages/food (tea/chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
- The subject has used tobacco-containing products and nicotine-containing products within 6 months
- The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
- The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1. mirabegron, low dose
Oral mirabegron 25 mg
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oral tablet
Autres noms:
IV solution
Autres noms:
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Expérimental: 2. mirabegron, middle dose
Oral mirabegron 50 mg
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oral tablet
Autres noms:
IV solution
Autres noms:
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Expérimental: 3. mirabegron, higher dose
Oral mirabegron 100 mg
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oral tablet
Autres noms:
IV solution
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Characterize the pharmacokinetic profile of 3 doses of oral mirabegron formulations with three different release rates vs. three doses of mirabegron administered intravenously
Délai: 2 months
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2 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Assess the safety and tolerability of three doses of orally administered mirabegron formulated with three different release rates
Délai: 2 months
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2 months
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Assess the safety and tolerability of intravenously administered mirabegron
Délai: 2 months
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2 months
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 178-CL-076
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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