Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01572753
First received: April 4, 2012
Last updated: September 11, 2012
Last verified: September 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2012 | ||||
| Last Updated Date | September 11, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
AUC0-24hrs, Day10: Area under the NN9924 concentration curve [ Time Frame: From time 0-24hrs after the 10th dosing ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01572753 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects | ||||
| Official Title ICMJE | Investigation of Optimal Dosing Conditions for NN9924 in Healthy Male Subjects | ||||
| Brief Summary | This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for NN9924 in healthy male subjects. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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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 | 157 | ||||
| Completion Date | September 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01572753 | ||||
| Other Study ID Numbers ICMJE | NN9924-3794, 2010-019653-17, U1111-1120-6776 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Public Access to Clinical Trials, Novo Nordisk A/S | ||||
| Study Sponsor ICMJE | Novo Nordisk | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novo Nordisk | ||||
| Verification Date | September 2012 | ||||
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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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