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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00851773 |
This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: NN9535 Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomised, Double Blind, Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Profiles of NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections. |
Enrollment: | 84 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: NN9535
0.1 mg once weekly, s.c. injection
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B: Experimental |
Drug: NN9535
0.2 mg once weekly, s.c. injection
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C: Experimental |
Drug: NN9535
0.4 mg once weekly, s.c. injection
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D: Experimental |
Drug: NN9535
0.4 mg once weekly for 1 week, 0,8 mg once weekly for 7 weeks, s.c. injection
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E: Experimental |
Drug: NN9535
0.8 mg once weekly, s.c. injection
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F: Experimental |
Drug: NN9535
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.6 mg once weekly for 6 weeks, s.c. injection
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G: Experimental |
Drug: NN9535
S.c. injection: 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by once weekly injections for 6 weeks. Dose to be determined based on safety and tolerability of previous dose steps. This dose-arm is optional and will only be implemented if the 0.8 mg is tolerated but the 1.6 mg is not. |
H1: Placebo Comparator |
Drug: placebo
0.1 mg once weekly, s.c. injection
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H2: Placebo Comparator |
Drug: placebo
0.2 mg once weekly, s.c. injection
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H3: Placebo Comparator |
Drug: placebo
0.4 mg once weekly, s.c. injection
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H4: Placebo Comparator |
Drug: placebo
0.4 mg once weekly for 1 week, 0,8 mg once weekly for 7 weeks, s.c. injection
|
H5: Placebo Comparator |
Drug: placebo
0.8 mg once weekly, s.c. injection
|
H6: Placebo Comparator |
Drug: placebo
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.6 mg once weekly for 6 weeks, s.c. injection
|
H7: Placebo Comparator |
Drug: placebo
S.c. injection: 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by once weekly injections for 6 weeks. Dose to be determined based on safety and tolerability of previous dose steps.
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Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN9535-3633, EudraCT No: 2008-006325-13 |
Study First Received: | February 25, 2009 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00851773 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Healthy |