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Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722540
First Posted: July 25, 2008
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.

Condition Intervention Phase
Growth Hormone Disorder Healthy Drug: NNC126-0083 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Safety and tolerability (adverse events, local tolerability, physical examination) [ Time Frame: 0 to 10 days after third dosing, (day 15-25 after first dose) ]

Secondary Outcome Measures:
  • Cmax, maximum concentration of IGF-I [ Time Frame: 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose) ]

Enrollment: 40
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Experimental: B Drug: NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Experimental: C Drug: NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Experimental: D Drug: NNC126-0083
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Experimental: E Drug: NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Drug: placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects with Japanese passport and Japanese born parents
  • Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
  • Subjects must be in good health according to age

Exclusion Criteria:

  • A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
  • History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
  • Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722540


Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00722540     History of Changes
Other Study ID Numbers: NN8630-1958
2008-001578-33 ( EudraCT Number )
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: February 8, 2017
Last Verified: February 2017