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

Phase 1

Completed

• Conditions: Healthy; Adult Growth Hormone Deficiency; Growth Hormone Disorder

• Registration Number: NCT00931476
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Primary Completion: 2000-06-08
• Study Completion: 2000-06-08
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Area under the hGH concentration-time curve (GH AUC0-24h)	from 0 to 24 hours following injection
Treatment Emergent Adverse Events	from 0 to 24 hours following injection
Maximum hGH concentration (GH Cmax)	from 0 to 24 hours following injection

Secondary Outcome Measures

Name	Time	Method
Area under the hGH concentration-time curve GH AUC0-∞)
Elimination half-life (GH t½)
Non-treatment Emergent Adverse Events
Time to maximum hGH concentration (GH tmax)
Growth Factors (IGF-I and IGFBP-3)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Honolulu, Hawaii, United States