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

NCT ID: NCT02894905

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-13
• Study Completion Date: 2017-08-16

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AL-335 (Cohort 1)

Participants with mild impaired renal function will receive a single oral dose of AL-335 800 milligram (mg) (given as 2\*400-mg tablets).

Group Type: EXPERIMENTAL

AL-335

Intervention Type: DRUG

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).

AL-335 (Cohort 2)

Participants with moderate impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).

Group Type: EXPERIMENTAL

AL-335

Intervention Type: DRUG

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).

AL-335 (Cohort 3)

Participants with severe impaired renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).

Group Type: EXPERIMENTAL

AL-335

Intervention Type: DRUG

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).

AL-335 (Cohort 4)

Participants with normal renal function will receive a single oral dose of AL-335 800 mg (given as 2\*400-mg tablets).

Group Type: EXPERIMENTAL

AL-335

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Orlando, Florida, United States

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

64294178HPC1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108225

Identifier Type: -

Identifier Source: org_study_id