NCT02442258

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

May 11, 2015

Last Update Submit

February 18, 2016

Conditions

Renal Impairment

Keywords

Renal Impairment

Outcome Measures

Primary Outcomes (10)

  • (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.

  • 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

  • Number of subjects with adverse events

    Total number of subjects with adverse events.

    Up to 30 days

  • 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.

  • 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.

  • (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.

  • 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.

  • 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.

  • (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.

  • (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.

Study Arms (6)

Group 1 - Mild Renal Impairment

EXPERIMENTAL

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

Drug: ABT-493Drug: ABT-530

Group 2 - Moderate Renal Impairment

EXPERIMENTAL

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

Drug: ABT-493Drug: ABT-530

Group 3 - Severe Renal Impairment

EXPERIMENTAL

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

Drug: ABT-493Drug: ABT-530

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

EXPERIMENTAL

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.

Drug: ABT-493Drug: ABT-530

Group 5 - Normal Renal Function

EXPERIMENTAL

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

Drug: ABT-493Drug: ABT-530

Group 6 - End Stage Renal Disease, Requiring Dialysis.

EXPERIMENTAL

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

Drug: ABT-493Drug: ABT-530

Interventions

ABT-493DRUG

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

Group 1 - Mild Renal ImpairmentGroup 2 - Moderate Renal ImpairmentGroup 3 - Severe Renal ImpairmentGroup 4 - End Stage Renal Disease, Not Yet on DialysisGroup 5 - Normal Renal FunctionGroup 6 - End Stage Renal Disease, Requiring Dialysis.
ABT-530DRUG

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

Group 1 - Mild Renal ImpairmentGroup 2 - Moderate Renal ImpairmentGroup 3 - Severe Renal ImpairmentGroup 4 - End Stage Renal Disease, Not Yet on DialysisGroup 5 - Normal Renal FunctionGroup 6 - End Stage Renal Disease, Requiring Dialysis.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Reference ID/Investigator# 132890

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 132889

Orlando, Florida, 32809, United States

Location

Site Reference ID/Investigator# 137332

Grafton, Auckland, 1010, New Zealand

Location

Related Publications (1)

  • Kosloski MP, Zhao W, Marbury TC, Preston RA, Collins MG, Pugatch D, Mensa F, Kort J, Liu W. Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01990-17. doi: 10.1128/AAC.01990-17. Print 2018 Mar.

    PMID: 29263061DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

glecaprevirpibrentasvir

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • David Pugatch, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

US(2)NZ(1)