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NCT Number: NCT02442258

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 137332, Grafton, Auckland, New Zealand

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-493

Drug

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

ABT-530

Drug

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 13, 2015
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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