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

NCT03189615 — Phase 1, Completed, 24 participants, H. Lundbeck A/S

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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

Registry	NCT03189615
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	H. Lundbeck A/S (Industry)
Conditions	Hepatic Impairment
Interventions	Lu AF35700 (Drug)
Dates	start 2017-05-14, primary completion 2018-02-28, completion 2018-04-23, first posted 2017-06-16, last updated 2018-05-04
Locations	1 site in Germany

-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

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+Arms and interventions

Arm	Type	Interventions
Patients with mild hepatic impairment (Group1)	Experimental	Drug: Lu AF35700
Patients with moderate hepatic impairment (Group 2)	Experimental	Drug: Lu AF35700
Healthy subjects (Group 3)	Experimental	Drug: Lu AF35700

Lu AF35700 (Drug): Single oral dose of 10 mg Lu AF35700

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
APEX	Munich	Germany

+Investigators

Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com

+Funding

NIH grants: 2016