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NCT03189615 Clinical Trial

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

Hepatic Impairment Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03189615
Other study ID # 17256A
Secondary ID 2016-004139-20
Status Completed
Phase Phase 1
First received
Last updated
Start date May 14, 2017
Est. completion date April 23, 2018

Study information
Verified date May 2018
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 23, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lu AF35700
Single oral dose of 10 mg Lu AF35700

Locations
Country Name City State
Germany APEX Munich

Sponsors (1)
Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

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