Effect of Food Intake on Pharmacokinetic Profiles of Z-338
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00920998
First received: June 15, 2009
Last updated: July 16, 2009
Last verified: July 2009
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2009 | ||||
| Last Updated Date | July 16, 2009 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetics of Z-338 [ Time Frame: 48 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00920998 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Food Intake on Pharmacokinetic Profiles of Z-338 | ||||
| Official Title ICMJE | A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers | ||||
| Brief Summary | To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers. |
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| Detailed Description | The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: Z-338
oral
Other Name: YM443 |
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| Study Arm (s) | Experimental: 1. Z-338
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
Intervention: Drug: Z-338 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 20 Years to 44 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00920998 | ||||
| Other Study ID Numbers ICMJE | 443-CL-503 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Director, Astellas Pharma, Inc | ||||
| Study Sponsor ICMJE | Astellas Pharma Inc | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Astellas Pharma Inc | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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