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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: ABT-530; Drug: ABT-493

Study type: Interventional

Funder types: Industry

Identifiers

NCT02442258

M13-600

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: All Subjects

• 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

In addition to the main inclusion criteria above for all subjects, the following criteria must be met for subjects with normal renal function enrolled in Group 5:

• 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

In addition to the main inclusion criteria for all subjects, the following criteria must be met for all subjects with renal impairment enrolled in Groups 1, 2, 3, 4 and 6:

• 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: - History of significant sensitivity to any drug.

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 6 patient groups

Group 1 - Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ABT-493

Drug: ABT-530

Group 2 - Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ABT-493

Drug: ABT-530

Group 3 - Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: ABT-493

Drug: ABT-530

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

Experimental group

Description:

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.

Treatment:

Drug: ABT-493

Drug: ABT-530

Group 5 - Normal Renal Function

Experimental group

Description:

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

Treatment:

Drug: ABT-493

Drug: ABT-530

Group 6 - End Stage Renal Disease, Requiring Dialysis.

Experimental group

Description:

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

Treatment:

Drug: ABT-493

Drug: ABT-530