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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Growth Hormone Disorder
• Intervention / Treatment: Drug: NNC126-0083; Drug: NNC126-0083; Drug: NNC126-0083; Drug: NNC126-0083; Drug: placebo; Drug: placebo; Drug: placebo; Drug: placebo; Drug: NNC126-0083; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E	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
Experimental: A	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
Experimental: B	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
Experimental: C	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
Experimental: D	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability (adverse events, local tolerability, physical examination)	0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax, maximum concentration of IGF-I	7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

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

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 25, 2008

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NN8630-1958; 2008-001578-33 (EudraCT Number)