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

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054

Official Title
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Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects

Conditions
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Heptic Impairment

Intervention / Treatment
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* Drug: Lu AE58054 encapsulated film-coated tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive). Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6) Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9) Group 3: Healthy subjects with normal hepatic function Other pre-defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with mild hepatic impairment (Group1)<br>8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054 | Drug: Lu AE58054 encapsulated film-coated tablets<br> <br> |
| Experimental: Patients with moderate hepatic impairment (Group 2)<br>8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054. | Drug: Lu AE58054 encapsulated film-coated tablets<br> <br> |
| Experimental: Healthy subjects (Group 3)<br>8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054. | Drug: Lu AE58054 encapsulated film-coated tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf) |  | 0 to 96 hours | 
| Maximum observed plasma concentration (Cmax) of Lu AE58054 |  | 0 to 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG) |  | Screening to day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AE58054, Hepatic impairment