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

Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03189615

Enrollment

Registered

2017-06-16

Start date

2017-05-14

Completion date

2018-04-23

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Brief summary

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

Interventions

DRUGLu AF35700

Single oral dose of 10 mg Lu AF35700

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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 Other protocol defined inclusion and

Design outcomes

Primary

Measure	Time frame	Description
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)	Predose to day 57 postdose	Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AF35700	Predose to day 57 postdose	Maximum observed plasma concentration (Cmax) of Lu AF35700

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026