Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

Renal Failure Clinical Trial

Official title:

Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03241147
• Other study ID #: 17278A
• Status: Terminated
• Phase: Phase 1
• Start date: July 25, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: September 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 24, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

-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

Exclusion Criteria:

-The subject has previously been dosed with Lu AF35700

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Lu AF35700
Single dose, 10 mg film coated tablet

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	AUC0-inf	Area under the Lu AF35700 plasma concentration-time curve from zero to infinity	Predose to day 57 postdose
Primary	Cmax	Maximum observed plasma concentration of Lu AF35700	Predose to day 57 postdose