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NCT00931476 Clinical Trial

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

Healthy Clinical Trial

Official title:
A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00931476
Other study ID # GHKIN-1253
Secondary ID
Status Completed
Phase Phase 1
First received June 30, 2009
Last updated February 23, 2017
Start date April 6, 2000
Est. completion date June 8, 2000

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date June 8, 2000
Est. primary completion date June 8, 2000
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Signed informed consent before any trial related activities

- Japanese and Caucasian males respectively

- Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis

- Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

• placebo

Locations
Country Name City State
United States Novo Nordisk Investigational Site Honolulu Hawaii

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the hGH concentration-time curve (GH AUC0-24h) from 0 to 24 hours following injection
Primary Maximum hGH concentration (GH Cmax) from 0 to 24 hours following injection
Primary Treatment Emergent Adverse Events from 0 to 24 hours following injection
Secondary Time to maximum hGH concentration (GH tmax)
Secondary Area under the hGH concentration-time curve GH AUC0-8)
Secondary Elimination half-life (GH t½)
Secondary Growth Factors (IGF-I and IGFBP-3)
Secondary Non-treatment Emergent Adverse Events
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