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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442258
• Other study ID #: M13-600
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2015
• Last updated: February 18, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
New Zealand	Site Reference ID/Investigator# 137332	Grafton, Auckland
United States	Site Reference ID/Investigator# 132890	Miami	Florida
United States	Site Reference ID/Investigator# 132889	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-493 study drug.	The AUC from time 0 to infinity represents the total drug exposure over time.	Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1.	No
Primary	Overall measurement of safety parameters	Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.	SUB-STUDY 1 - Duration of 14 days SUB-STUDY 2 - Duration of 16 Days	Yes
Primary	Number of subjects with adverse events	Total number of subjects with adverse events.	Up to 30 days	Yes
Primary	Maximum plasma concentration (Cmax) of the ABT-493 study drug.	The peak concentration that a drug achieves in a specified compartment after the drug has been administrated and before administration of a second dose.	(SUB-STUDY 1) Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1. (SUB-STUDY 2) Prior to dosing (0-hour), and at 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period.	No
Primary	Area under the plasma concentration-time curve (AUC) for the ABT-493 study drug.	AUC reflects the actual body exposure to drug after administration of a dose of the drug.	(SUB-STUDY 1) Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1. (SUB-STUDY 2) Prior to dosing (0-hour), and at 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period.	No
Primary	(SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-530 study drug.	The AUC from time 0 to infinity represents the total drug exposure over time.	Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1.	No
Primary	Maximum plasma concentration (Cmax) of the ABT-530 study drug.	The peak concentration that a drug achieves in a specified compartment after the drug has been administrated and before administration of a second dose.	(SUB-STUDY 1) Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1. (SUB-STUDY 2) Prior to dosing (0-hour), 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period.	No
Primary	Area under the plasma concentration-time curve (AUC) for the ABT-530 study drug.	AUC reflects the actual body exposure to drug after administration of a dose of the drug.	(SUB-STUDY 1) Prior to dosing (0-hour), 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hours and 144 hours after dosing on Study Day 1. (SUB-STUDY 2) Prior to dosing (0-hour), and at 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period.	No
Primary	(SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-493 study drug.	The AUC during hemodialysis represents the total drug exposure over time.	Prior to dosing (0-hour), and at 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period. Additional samples will be collected at 4, 5, and 6 hours after dosing on Study Day 1 of Period 2 only.	No
Primary	(SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-530 study drug.	The AUC during hemodialysis represents the total drug exposure over time.	Prior to dosing (0-hour), and at 1, 2, 3, 9, 12, 16, 24 hours after dosing on Study Day 1 of each Period. Additional samples will be collected at 4, 5 and 6 hours after dosing on Study Day 1 of Period 2 only.	No