NCT03241147

Brief Summary

This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

July 25, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

August 2, 2017

Last Update Submit

September 26, 2019

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (2)

  • AUC0-inf

    Area under the Lu AF35700 plasma concentration-time curve from zero to infinity

    Predose to day 57 postdose

  • Cmax

    Maximum observed plasma concentration of Lu AF35700

    Predose to day 57 postdose

Study Arms (4)

Subjects with severe renal impairment (Group A)

EXPERIMENTAL
Drug: Lu AF35700

Healthy subjects (Group B)

EXPERIMENTAL
Drug: Lu AF35700

Subjects with moderate renal impairment (Group C)

EXPERIMENTAL
Drug: Lu AF35700

Subjects with mild renal impairment (Group D)

EXPERIMENTAL
Drug: Lu AF35700

Interventions

Lu AF35700DRUG

Single dose, 10 mg film coated tablet

Healthy subjects (Group B)Subjects with mild renal impairment (Group D)Subjects with moderate renal impairment (Group C)Subjects with severe renal impairment (Group A)

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
  • Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
  • The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
  • Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min

You may not qualify if:

  • The subject has previously been dosed with Lu AF35700

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APEX

Munich, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Lu AF35700

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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

August 2, 2017

First Posted

August 7, 2017

Study Start

July 25, 2017

Primary Completion

July 17, 2019

Study Completion

July 24, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

DE(1)