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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00722540
First received: July 23, 2008
Last updated: November 6, 2012
Last verified: November 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722540

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Jensen, DVM, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00722540     History of Changes
Other Study ID Numbers: NN8630-1958, 2008-001578-33
Study First Received: July 23, 2008
Last Updated: November 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 21, 2014