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Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

NCT03212131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-05-24

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics).

In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.

Conditions

  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Growth Hormone Deficiency in Children

Interventions

DRUG

Somapacitan

3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2018-03-08
Completion
2018-03-08
FDA Drug
Yes

Countries

  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212131 on ClinicalTrials.gov