MedDataX Logo

Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects

NCT ID: NCT03189615

Last Updated: 2018-05-04

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-14

Study Completion Date

2018-04-23

Brief Summary

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

The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700

Related Clinical Trials

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

Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects

NCT02231450

Heptic Impairment
COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

NCT01456663

Hepatic Impairment
COMPLETED PHASE1

Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

NCT01565902

Hepatic Impairment
COMPLETED PHASE1

A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment

NCT05537142

Healthy Participants
COMPLETED PHASE1

A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

NCT01356550

Healthy Volunteer
COMPLETED 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.

Hepatic Impairment

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

Study Groups

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

Patients with mild hepatic impairment (Group1)

Group Type EXPERIMENTAL

Lu AF35700

Intervention Type DRUG

Single oral dose of 10 mg Lu AF35700

Patients with moderate hepatic impairment (Group 2)

Group Type EXPERIMENTAL

Lu AF35700

Intervention Type DRUG

Single oral dose of 10 mg Lu AF35700

Healthy subjects (Group 3)

Group Type EXPERIMENTAL

Lu AF35700

Intervention Type DRUG

Single oral dose of 10 mg Lu AF35700

Interventions

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

Lu AF35700

Single oral dose of 10 mg Lu AF35700

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
* Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)

Exclusion Criteria

* Subjects previously been dosed with Lu AF35700
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

APEX

Munich, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-004139-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17256A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A PK and Safety Study in Subjects With Hepatic Impairment
NCT01431833 COMPLETED PHASE1
Effect of Hepatic Impairment on LDK378 Pharmacokinetics
NCT01950481 COMPLETED PHASE1
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
NCT00692341 COMPLETED PHASE1
Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
NCT01358565 COMPLETED PHASE1
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
NCT01767688 COMPLETED PHASE1
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
NCT01516047 COMPLETED PHASE1
The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics
NCT04252495 COMPLETED PHASE1
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
NCT01298063 COMPLETED PHASE1
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
NCT04154774 COMPLETED PHASE1
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
NCT02857868 COMPLETED PHASE1
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
NCT02318836 COMPLETED PHASE1
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
NCT06736223 COMPLETED PHASE1
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
NCT02121860 COMPLETED PHASE1
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061 COMPLETED PHASE1
A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196
NCT04867941 COMPLETED PHASE1
Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects
NCT01433458 COMPLETED PHASE1
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
NCT04587622 COMPLETED PHASE1
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
NCT04193436 COMPLETED PHASE1
A Study of TAK-279 in Adults With or Without Liver Damage
NCT05976321 COMPLETED PHASE1
HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects
NCT04252417 TERMINATED PHASE1
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
NCT03824678 COMPLETED PHASE1
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
NCT01594957 COMPLETED PHASE1
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
NCT06576765 COMPLETED PHASE1
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
NCT04116476 COMPLETED PHASE1
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
NCT04643795 COMPLETED PHASE1