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

NCT02894905 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10822564294178HPC1009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Concentration (Cmax) of AL-335

  The Cmax is the maximum observed concentration of analyte (AL-335).

  Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.

  Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose

• Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity)

  The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to follow-up (Approximately 30-35 days after study drug administration)

Study Arms (4)

AL-335 (Cohort 1)

EXPERIMENTAL

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

Drug: AL-335

AL-335 (Cohort 2)

EXPERIMENTAL

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

Drug: AL-335

AL-335 (Cohort 3)

EXPERIMENTAL

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

Drug: AL-335

AL-335 (Cohort 4)

EXPERIMENTAL

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

Drug: AL-335

Interventions

AL-335 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 1); AL-335 (Cohort 2); AL-335 (Cohort 3); AL-335 (Cohort 4)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

adafosbuvir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: September 13, 2016
• Primary Completion: August 8, 2017
• Study Completion: August 16, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

US (2)