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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00722540

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
Healthy	Drug: NNC126-0083 Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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:

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
A: Experimental	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
B: Experimental	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
C: Experimental	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
D: Experimental	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
E: Experimental	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

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

Locations

Germany

Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Lene Jensen, DVM, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN8630-1958, EudraCT No: 2008-001578-33
Study First Received:	July 23, 2008
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00722540 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 11, 2009