MedDataX Logo

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

NCT ID: NCT00722540

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

NCT00715689

Growth Hormone Disorder Adult Growth Hormone Deficiency
COMPLETED PHASE2

Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

NCT01034202

Growth Hormone Disorder Healthy
COMPLETED PHASE1

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

NCT00936403

Growth Hormone Disorder Growth Hormone Deficiency in Children
COMPLETED PHASE2

A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

NCT00931476

Growth Hormone Disorder Adult Growth Hormone Deficiency Healthy
COMPLETED PHASE1

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

NCT00184743

Growth Hormone Disorder Adult Growth Hormone Deficiency
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Hormone Disorder Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

NNC126-0083

Intervention Type DRUG

Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

placebo

Intervention Type DRUG

Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

B

Group Type EXPERIMENTAL

NNC126-0083

Intervention Type DRUG

Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

placebo

Intervention Type DRUG

Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

C

Group Type EXPERIMENTAL

NNC126-0083

Intervention Type DRUG

Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

placebo

Intervention Type DRUG

Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

D

Group Type EXPERIMENTAL

NNC126-0083

Intervention Type DRUG

Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

placebo

Intervention Type DRUG

Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

E

Group Type EXPERIMENTAL

NNC126-0083

Intervention Type DRUG

Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

placebo

Intervention Type DRUG

Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NNC126-0083

Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

Intervention Type DRUG

NNC126-0083

Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

Intervention Type DRUG

NNC126-0083

Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

Intervention Type DRUG

NNC126-0083

Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

placebo

Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

placebo

Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

placebo

Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

placebo

Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

NNC126-0083

Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks

Intervention Type DRUG

placebo

Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1111/j.1365-2265.2010.03863.x.

Reference Type RESULT
PMID: 20718773 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-001578-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN8630-1958

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
NCT00184730 COMPLETED PHASE3
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
NCT03075644 COMPLETED PHASE3
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
NCT01514500 COMPLETED PHASE1
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
NCT01109017 COMPLETED
Effect of Growth Hormone in Children With Growth Hormone Deficiency
NCT00262249 COMPLETED PHASE3
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
NCT01562834 COMPLETED PHASE4
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
NCT01502124 COMPLETED PHASE3
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
NCT01927861 COMPLETED PHASE3
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency
NCT00191360 COMPLETED PHASE3
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
NCT00488124 COMPLETED PHASE2
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
NCT01440686 COMPLETED PHASE1
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
NCT00184678 COMPLETED PHASE3
A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
NCT07259564 NOT_YET_RECRUITING PHASE2
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
NCT01822340 COMPLETED PHASE2
Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
NCT01734447 COMPLETED PHASE4
Special Survey for Long Term Application
NCT01516229 COMPLETED
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
NCT01778023 COMPLETED PHASE3
Safety and Efficacy of Long-term Somatropin Treatment in Adults
NCT01543880 COMPLETED
A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
NCT01435629 COMPLETED
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
NCT02418767 COMPLETED PHASE1
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
NCT02558829 COMPLETED PHASE3
Pilot Study of Growth Hormon to Treat SMA Typ II and III
NCT00533221 COMPLETED PHASE2
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
NCT00567385 COMPLETED PHASE4
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
NCT02382939 COMPLETED PHASE3
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
NCT00191165 COMPLETED PHASE3