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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 13, 2016

Primary Completion Date

August 8, 2017

Study Completion Date

August 16, 2017

Conditions
Renal Insufficiency
Interventions
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).

Trial Locations (2)

Unknown

Orlando

Knoxville

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02894905 - A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 | Biotech Hunter | Biotech Hunter