NCT02894905

A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335

An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Single-dose Pharmacokinetics of AL-335

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	AL-335	Participants with various degrees of impaired renal function (mild \[Cohort 1\], moderate \[Cohort 2\], severe \[Cohort 3\]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).

Timeline

• Start date: 2016-09-13
• Primary completion: 2017-08-08
• Completion: 2017-08-16
• First posted: 2016-09-09
• Last updated: 2017-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study