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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2018-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

NCT06813781

Hepatic Impairment

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics of LY2624803 in Subjects With Hepatic Impairment

NCT01257178

Insomnia

TERMINATED PHASE1

Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

NCT00545259

de Novo Liver Transplantation

COMPLETED PHASE1

A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men

NCT04123288

Healthy Subjects

COMPLETED PHASE1

A Study of Bomedemstat (MK-3543) in Participants With Mild or Moderate Hepatic Impairment (MK-3543-023)

NCT07049939

Hepatic Insufficiency

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal hepatic function

Subjects with normal hepatic function

Group Type EXPERIMENTAL

Somapacitan

Intervention Type DRUG

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

Mild hepatic impairment

Subjects with mild hepatic impairment

Group Type EXPERIMENTAL

Somapacitan

Intervention Type DRUG

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

Moderate hepatic impairment

Subjects with moderate hepatic impairment

Group Type EXPERIMENTAL

Somapacitan

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Somapacitan

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female aged 18-75 years (both inclusive)
* Body mass index of 18.5-39.9 kg/sqm (both inclusive)
* Subjects with normal hepatic function or hepatic impairment (mild or moderate)

Exclusion Criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration
* Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration
* Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
* Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes