ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00722540
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Growth Hormone Disorder Healthy Drug: NNC126-0083 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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) ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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