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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Treatments

Drug: somatropin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931476

GHKIN-1253

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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