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Clinical Trials/NCT00722540
NCT00722540
Completed
Phase 1

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

Novo Nordisk A/S1 site in 1 country40 target enrollmentJuly 2008
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ConditionsGrowth Hormone DisorderHealthy
InterventionsplaceboNNC126-0083
DrugsNNC126-0083placebo

Overview

Phase
Phase 1
Intervention
placebo
Conditions
Growth Hormone Disorder
Sponsor
Novo Nordisk A/S
Enrollment
40
Locations
1
Primary Endpoint
Safety and tolerability (adverse events, local tolerability, physical examination)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
April 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

C

Intervention: placebo

A

Intervention: NNC126-0083

A

Intervention: placebo

B

Intervention: NNC126-0083

B

Intervention: placebo

C

Intervention: NNC126-0083

D

Intervention: NNC126-0083

D

Intervention: placebo

E

Intervention: NNC126-0083

E

Intervention: placebo

Outcomes

Primary Outcomes

Safety and tolerability (adverse events, local tolerability, physical examination)

Time Frame: 0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary Outcomes

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

Study Sites (1)

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