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

Healthy Clinical Trial

Official title:

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722540
• Other study ID #: NN8630-1958
• Secondary ID: 2008-001578-33
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2008
• Last updated: February 6, 2017
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Hormone Disorder
• Healthy

Intervention

Drug:
• NNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• placebo
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
• NNC126-0083
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
• placebo
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (adverse events, local tolerability, physical examination)		0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary	Cmax, maximum concentration of IGF-I		7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)

External Links

•   Clinical Trials at Novo Nordisk