Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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This is an open-label, single dose study designed to assess the pharmacokinetics and safety of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal function.

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Detailed Description

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Up to 48 subjects will be selected and enrolled according to the subject selection criteria: 8 subjects with mild renal impairment (Group 1), 8 subjects with moderate renal impairment (Group 2), 8 subjects with severe renal impairment (Group 3), 8 subjects with end stage renal disease that are not yet on dialysis (Group 4), 8 healthy subjects with normal renal function (Group 5), and 8 subjects with end stage renal disease on hemodialysis (Group 6).

Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1 - Mild Renal Impairment

Subjects with mild renal impairment. eGFR (by MDRD equation) range 60 - 89 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Group 2 - Moderate Renal Impairment

Subjects with moderate renal impairment. eGFR (by MDRD equation) range 30 - 59 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Group 3 - Severe Renal Impairment

Subjects with severe renal impairment. eGFR (by MDRD equation) range 15 - 29 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Group 4 - End Stage Renal Disease, Not Yet on Dialysis

Subjects with end stage renal disease, not yet on dialysis. eGFR (by MDRD equation) range \< 15 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Group 5 - Normal Renal Function

Subjects with normal renal function. eGFR (by MDRD equation) range ≥ 90 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Group 6 - End Stage Renal Disease, Requiring Dialysis.

Subjects with end stage renal disease, requiring dialysis. eGFR (by MDRD equation) \< 15 mL/min/1.73 m2 as determined at Screening.

Group Type EXPERIMENTAL

ABT-493

Intervention Type DRUG

A single dose of ABT-493 will be given orally in combination with ABT-530.

ABT-530

Intervention Type DRUG

A single dose of ABT-530 will be given orally in combination with ABT-493.

Interventions

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ABT-493

A single dose of ABT-493 will be given orally in combination with ABT-530.

Intervention Type DRUG

ABT-530

A single dose of ABT-530 will be given orally in combination with ABT-493.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females must have negative results for pregnancy tests performed:

* At Screening on a urine specimen, and
* On a serum sample obtained on Study Day -2 (prior to dosing).
* Body Mass Index (BMI) is ≥ 18 to ≤ 38 kg/m2, inclusive.
* Body Weight \> 50 kg.

Subjects with Normal Renal Function

* Judged to be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ECG).
* At screening, estimated GFR (by MDRD equation) should be ≥ 90 mL/min/1.73 m2.

Subject with Renal Impairment

* Judged to be in stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile and ECG.
* Presence of chronic renal impairment as indicated by medical history and a screening estimated GFR (by MDRD equation) \< 90 mL/min/1.73 m2.
* Subjects with ESRD undergoing hemodialysis should have been receiving dialysis for at least 1 month.

Exclusion Criteria

* Pregnant or breastfeeding female.
* Recent (6-month) history of drug or alcohol abuse.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
* Subjects on strict vegetarian diet.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes