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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00931476
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 41.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder; Adult Growth Hormone Deficiency; Healthy	Drug: somatropin; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 6, 2000
• Actual Primary Completion Date: Jun 8, 2000
• Actual Study Completion Date: Jun 8, 2000

Outcome Measures

Primary Outcome Measures

1. Area under the hGH concentration-time curve (GH AUC0-24h) [from 0 to 24 hours following injection]

2. Maximum hGH concentration (GH Cmax) [from 0 to 24 hours following injection]

3. Treatment Emergent Adverse Events [from 0 to 24 hours following injection]

Secondary Outcome Measures

1. Time to maximum hGH concentration (GH tmax) []

2. Area under the hGH concentration-time curve GH AUC0-∞) []

3. Elimination half-life (GH t½) []

4. Growth Factors (IGF-I and IGFBP-3) []

5. Non-treatment Emergent Adverse Events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814-4224

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00931476
• Other Study ID Numbers: GHKIN-1253
• First Posted: Jul 2, 2009
• Last Update Posted: Feb 27, 2017
• Last Verified: Feb 1, 2017

Study Results

No Results Posted as of Feb 27, 2017