A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901

NCT ID: NCT02975388

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-20
• Study Completion Date: 2017-07-06

Brief Summary

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis.

Conditions

Renal Impairment

Study Design

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

Study Groups

Label: RO7079901 (Mild) (Part 1)

Participants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.

Group Type: EXPERIMENTAL

RO7079901

Intervention Type: DRUG

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

RO7079901 (Moderate) (Part 1)

Participants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.

Group Type: EXPERIMENTAL

RO7079901

Intervention Type: DRUG

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

RO7079901 (Severe) (Part 1)

Participants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.

Group Type: EXPERIMENTAL

RO7079901

Intervention Type: DRUG

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

RO7079901 (Normal) (Part 1)

Control group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901.

Group Type: ACTIVE_COMPARATOR

RO7079901

Intervention Type: DRUG

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

RO7079901 (End-stage) (Part 2)

Participants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901.

Group Type: EXPERIMENTAL

RO7079901

Intervention Type: DRUG

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

Interventions

RO7079901

Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body weight of at least 45 kilograms (kg)

Control group participants, Part 1 only:

• Normal renal function based on creatinine clearance greater than or equal to (>=) 90 milliliters per minute (mL/min) at the Screening visit
• Healthy for age-group, as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)

Participants with renal impairment, Part 1 only:

• Reduced renal function based on estimated creatinine clearance at the Screening visit. Creatinine clearance can be estimated from serum creatinine concentration at the Screening visit using the Cockcroft-Gault equation, or be a historical measured value obtained within the preceding 3 months. Participants with severe, moderate or mild renal impairment must have creatinine clearance of less than or equal to (<=) 29, 30 to 59, or 60 to 89 mL/min, respectively
• Stable renal function. The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days (one of which can be a historical value within the last 3 months). Renal function will be considered stable if the 2 serum creatinine values differ by <=30 percent (%) of the lower value

Participants with end-stage renal disease in Part 2 only:

• Reduced renal function with a clinical diagnosis of end-stage renal disease requiring renal replacement therapy
• Receiving hemodialysis for more than 3 months at the time of the Screening visit

Exclusion Criteria

• Recipient of a renal transplant (Part 1 only)
• Presence of renal carcinoma, or acute renal disease caused by infection or drug toxicity
• Nephrotic syndrome (defined as plasma albumin less than [<] 3 grams per deciliter [g/dL] and/or proteinuria greater than [>] 3 grams per day [g/day])
• Hemoglobin concentration <10 g/dL, or <9 g/dL for participants with end-stage renal disease
• Potassium concentration >5.5 millimoles per liter (mmol/L)
• Clinically significant liver disease
• Uncontrolled blood pressure
• Any condition associated with intra-vascular volume depletion
• Any unstable clinically significant disease
• Any other ongoing condition or disease (apart from renal dysfunction), or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study
• Major surgery or significant traumatic injury <28 days prior to the first administration (excluding biopsies), or anticipation of the need for major surgery during study treatment
• Recent history of alcoholism, drug abuse, or addiction within the last year prior to screening
• Positive test at Screening of any of the following: Hepatitis A, Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)
• Clinically significant change in disease status as judged by the investigator, or any major illness within the 4 weeks prior to the Screening visit, or febrile illness within 14 days prior to the Screening visit
• Use of prohibited medications, or alteration to a concomitant medication treatment regimen considered relevant by the investigator within 14 days before the Screening visit
• Known history of clinically significant hypersensitivity or severe allergic reaction to any drug, in particular antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams)
• Participation in another clinical study with an investigational drug or device within the 1 month preceding the Screening vist
• Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the Screening visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-LaRoche

Locations

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

DaVita Clinical Research

Minneapolis, Minnesota, United States

Prism Clinical Research

Saint Paul, Minnesota, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

NP39380

Identifier Type: -

Identifier Source: org_study_id