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

Completed · Phase 1

Conditions studied: Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT02894905

Run by

Janssen Research & Development, LLC

People needed

24

Starts

2016-09-13

Expected to finish

2017-08-16

Last updated by the study team

2017-12-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohorts 1-4:
• Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg
• Participants must agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (eg, contraceptive requirements)
• Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after study drug administration
• Male participant must agree not to donate sperm from enrollment (Day 1) in the study until at least 30 days after receiving the study drug
• Cohorts 1-3:
• Participant must have stable renal function
• Participant must be otherwise healthy except for the renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
• Participants must have an estimated glomerular filtration rate (eGFR) less than (<) 90 milliLiter per minute per 1.73 meter square (mL/min/1.73m\^2). Mild renal impairment (eGFR 60 to <90 mL/min/1.73m\^2); moderate renal impairment (eGFR 30 to <60 mL/min/1.73m\^2); severe renal impairment (eGFR <30 mL/min/1.73m\^2 not requiring dialysis)
• Cohort 4:
• Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening
• Participants must have an eGFR greater than or equal to (>=) 90 mL/min/1.73m\^2

You may not qualify if…

• Cohorts 1-4:
• Participant has a history of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
• Participant who is on a vegetarian diet or who takes creatine supplements, and who has a non-standard muscle mass, example (eg), amputation, malnutrition, muscle wasting, or extremely muscular (body building)
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
• Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
• Participant who smokes more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months before screening until the end of the study
• Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of the Informed Consent Form (ICF) onwards until 30 days after study drug administration
• Participant is a man who plans to father a child while enrolled in this study (Day 1) until 30 days after study drug administration.
• Cohorts 1-3:
• Participant requires dialysis
• Participant with imminent renal replacement therapy (ie, during the study period)

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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