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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493 | Drug | A single dose of ABT-493 will be given orally in combination with ABT-530. |
|
| Measure | Description | Time Frame |
|---|---|---|
| (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. |
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Inclusion Criteria: All Subjects
Females must have negative results for pregnancy tests performed:
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:
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:
Exclusion Criteria: - History of significant sensitivity to any drug.
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| Name | Affiliation | Role |
|---|---|---|
| David Pugatch, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 132890 | Miami | Florida | 33136 | United States | ||
| Site Reference ID/Investigator# 132889 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29263061 | Derived | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
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|
| 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. |
|
| ABT-530 | Drug | A single dose of ABT-530 will be given orally in combination with ABT-493. |
|
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. |
| Orlando |
| Florida |
| 32809 |
| United States |
| Site Reference ID/Investigator# 137332 | Grafton, Auckland | 1010 | New Zealand |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |