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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Lu AF35700

• Registration Number: NCT03189615
• Lead Sponsor: H. Lundbeck A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-14
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2018-02-28
• Study Completion: 2018-04-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with moderate hepatic impairment (Group 2)	Lu AF35700	-
Healthy subjects (Group 3)	Lu AF35700	-
Patients with mild hepatic impairment (Group1)	Lu AF35700	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

APEX; 🇩🇪 Munich, Germany