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

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ClinicalTrials.gov Identifier: NCT02442258
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: ABT-493 Drug: ABT-530 Phase 1

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: 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.
Drug: ABT-493
A single dose of ABT-493 will be given orally in combination with ABT-530.

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

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

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

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

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

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

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

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

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

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

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




Primary Outcome Measures :
  1. (SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-493 study drug. [ Time Frame: 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. ]
    The AUC from time 0 to infinity represents the total drug exposure over time.

  2. Overall measurement of safety parameters [ Time Frame: SUB-STUDY 1 - Duration of 14 days SUB-STUDY 2 - Duration of 16 Days ]
    Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.

  3. Number of subjects with adverse events [ Time Frame: Up to 30 days ]
    Total number of subjects with adverse events.

  4. Maximum plasma concentration (Cmax) of the ABT-493 study drug. [ Time Frame: (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. ]
    The peak concentration that a drug achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

  5. Area under the plasma concentration-time curve (AUC) for the ABT-493 study drug. [ Time Frame: (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. ]
    AUC reflects the actual body exposure to drug after administration of a dose of the drug.

  6. (SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-530 study drug. [ Time Frame: 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. ]
    The AUC from time 0 to infinity represents the total drug exposure over time.

  7. Maximum plasma concentration (Cmax) of the ABT-530 study drug. [ Time Frame: (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. ]
    The peak concentration that a drug achieves in a specified compartment after the drug has been administrated and before administration of a second dose.

  8. Area under the plasma concentration-time curve (AUC) for the ABT-530 study drug. [ Time Frame: (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. ]
    AUC reflects the actual body exposure to drug after administration of a dose of the drug.

  9. (SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-493 study drug. [ Time Frame: 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. ]
    The AUC during hemodialysis represents the total drug exposure over time.

  10. (SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-530 study drug. [ Time Frame: 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. ]
    The AUC during hemodialysis represents the total drug exposure over time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442258


Locations
United States, Florida
Site Reference ID/Investigator# 132890
Miami, Florida, United States, 33136
Site Reference ID/Investigator# 132889
Orlando, Florida, United States, 32809
New Zealand
Site Reference ID/Investigator# 137332
Grafton, Auckland, New Zealand, 1010
Sponsors and Collaborators
AbbVie
Investigators
Study Director: David Pugatch, MD AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02442258     History of Changes
Other Study ID Numbers: M13-600
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by AbbVie:
Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases