NCT00931476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2000

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2000

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

June 30, 2009

Last Update Submit

February 23, 2017

Conditions

Growth Hormone DisorderAdult Growth Hormone DeficiencyHealthy

Outcome Measures

Primary Outcomes (3)

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

    from 0 to 24 hours following injection

  • Maximum hGH concentration (GH Cmax)

    from 0 to 24 hours following injection

  • Treatment Emergent Adverse Events

    from 0 to 24 hours following injection

Secondary Outcomes (5)

  • 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

Interventions

somatropinDRUG
placeboDRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Honolulu, Hawaii, 96814-4224, United States

Location

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

April 6, 2000

Primary Completion

June 8, 2000

Study Completion

June 8, 2000

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

US(1)