Renal ImpairmentPhase 1NCT02442258
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
A Phase 1 study testing ABT-493 and ABT-530 in people with Renal Impairment, run by AbbVie at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- ABT-493 and ABT-530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Site Reference ID/Investigator# 132890
Miami, Florida, 33136
Site Reference ID/Investigator# 132889
Orlando, Florida, 32809
New Zealand1 site
Site Reference ID/Investigator# 137332
Grafton, Auckland, 1010
About this study
Official title: Evaluation of the 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.
Read the 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).
- Conditions
- Renal Impairment
- Being tested
- ABT-493, ABT-530
- Keywords
- Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-493Drug
A single dose of ABT-493 will be given orally in combination with ABT-530.
ABT-530Drug
A single dose of ABT-530 will be given orally in combination with ABT-493.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ABT-493; Drug: 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. Receives: Drug: ABT-493; Drug: 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. Receives: Drug: ABT-493; Drug: 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. Receives: Drug: ABT-493; Drug: 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. Receives: Drug: ABT-493; Drug: 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. Receives: Drug: ABT-493; Drug: ABT-530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: (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.
Measured: (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.
Measured: 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.
Measured: (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.
Measured: (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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Pugatch, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442258
- Sponsor's protocol ID
- M13-600
- Status last verified
- Feb 2016
- First submitted
- 11 May 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29263061