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

ClinicalTrials.gov Identifier:

NCT00722540

First received: July 23, 2008

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 23, 2008

Last Updated Date

November 6, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00722540 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Growth Hormone Disorder
Healthy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Interventions:
- Drug: NNC126-0083
- Drug: placebo
Experimental: B
Interventions:
- Drug: NNC126-0083
- Drug: placebo
Experimental: C
Interventions:
- Drug: NNC126-0083
- Drug: placebo
Experimental: D
Interventions:
- Drug: NNC126-0083
- Drug: placebo
Experimental: E
Interventions:
- Drug: NNC126-0083
- Drug: placebo

Publications *

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):769-76.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00722540

Other Study ID Numbers ^ICMJE

NN8630-1958, 2008-001578-33

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lene Jensen, DVM, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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