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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-003876-12 | EudraCT Number |
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The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.
Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast).
The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCAS-F | Experimental | YM178 OCAS tablet (OCAS-Fast) taken orally under fasted and fed condition |
|
| OCAS-S | Experimental | YM178 OCAS tablet (OCAS-Slow) taken orally under fasted and fed condition |
|
| OCAS-M | Experimental | YM178 OCAS tablet (OCAS-Medium) taken orally under fasted and fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM178 modified release (OCAS) | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile of OCAS and IR assessed by plasma concentration | AUC0-12h (Area under the plasma concentration - time curve from t=0 to t=12h) Cmax (Maximum concentration), tmax (Time to attain Cmax) and Ctrough (Pre-dose plasma concentration) | Day 1 & Day 6 - Day 8 |
| Pharmacokinetics profile of OCAS assessed by plasma concentration | AUC0-24h (Area under the plasma concentration - time curve from t=0 to t=24h) Cmax, Tmax and Ctrough | Day 8 |
| Pharmacokinetics profile of IR assessed by plasma concentration | AUC0-12h , AUC12-24h (Area under the plasma concentration - time curve from t=12 to t=24h), AUC0-24h, PTR (Peak trough ratio), Cmax, Tmax and Ctrough | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of safety parameters through assessment of vital signs, adverse events, Electrocardiogram (ECG) and clinical laboratory assessments | Baseline until Post Study Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharma Bio-Research B.V. | Zuidlaren | 9471 GP | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497763 | Background | Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014. |
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| YM178 immediate release (IR) | Drug | oral |
|
|
| ID | Term |
|---|---|
| C520025 | mirabegron |
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