NCT03241147

Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	Lu AF35700	Single dose, 10 mg film coated tablet

Timeline

• Start date: 2017-07-25
• Primary completion: 2019-07-17
• Completion: 2019-07-24
• First posted: 2017-08-07
• Last updated: 2019-09-30

Locations

1 site across 1 country: Germany