NCT03189615

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

June 14, 2017

Last Update Submit

May 3, 2018

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

  • 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

  • Maximum observed plasma concentration (Cmax) of Lu AF35700

    Maximum observed plasma concentration (Cmax) of Lu AF35700

    Predose to day 57 postdose

Study Arms (3)

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

Interventions

Lu AF35700DRUG

Single oral dose of 10 mg Lu AF35700

Healthy subjects (Group 3)Patients with mild hepatic impairment (Group1)Patients with moderate hepatic impairment (Group 2)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Subjects previously been dosed with Lu AF35700

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APEX

Munich, Germany

Location

MeSH Terms

Interventions

Lu AF35700

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

May 14, 2017

Primary Completion

February 28, 2018

Study Completion

April 23, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

DE(1)