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

Novo Nordisk A/S86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Healthy

Interventions

somatropinDRUG

placeboDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

Area under the hGH concentration-time curve (GH AUC0-24h)

Time frame: from 0 to 24 hours following injection

Maximum hGH concentration (GH Cmax)

Time frame: from 0 to 24 hours following injection

Treatment Emergent Adverse Events

Time frame: from 0 to 24 hours following injection

Secondary Outcomes

Time to maximum hGH concentration (GH tmax)

Area under the hGH concentration-time curve GH AUC0-∞)

Elimination half-life (GH t½)

Growth Factors (IGF-I and IGFBP-3)

Non-treatment Emergent Adverse Events

Data from ClinicalTrials.gov

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