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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02442258




Registration number
NCT02442258
Ethics application status
Date submitted
11/05/2015
Date registered
13/05/2015
Date last updated
22/02/2016

Titles & IDs
Public title
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
Scientific title
Evaluation of the Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
Secondary ID [1] 0 0
M13-600
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Impairment 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-493
Treatment: Drugs - ABT-530

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.

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.

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.

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.

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.

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.


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

Treatment: Drugs: ABT-530
A single dose of ABT-530 will be given orally in combination with ABT-493.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
(SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-493 study drug.
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
Overall measurement of safety parameters
Timepoint [2] 0 0
SUB-STUDY 1 - Duration of 14 days SUB-STUDY 2 - Duration of 16 Days
Primary outcome [3] 0 0
Number of subjects with adverse events
Timepoint [3] 0 0
Up to 30 days
Primary outcome [4] 0 0
Maximum plasma concentration (Cmax) of the ABT-493 study drug.
Timepoint [4] 0 0
(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.
Primary outcome [5] 0 0
Area under the plasma concentration-time curve (AUC) for the ABT-493 study drug.
Timepoint [5] 0 0
(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.
Primary outcome [6] 0 0
(SUB-STUDY 1) Area under the plasma concentration-time curve (AUC) from time 0 to infinity for the ABT-530 study drug.
Timepoint [6] 0 0
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.
Primary outcome [7] 0 0
Maximum plasma concentration (Cmax) of the ABT-530 study drug.
Timepoint [7] 0 0
(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.
Primary outcome [8] 0 0
Area under the plasma concentration-time curve (AUC) for the ABT-530 study drug.
Timepoint [8] 0 0
(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.
Primary outcome [9] 0 0
(SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-493 study drug.
Timepoint [9] 0 0
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.
Primary outcome [10] 0 0
(SUB-STUDY 2) Area under the plasma concentration-time curve (AUC) during hemodialysis for the ABT-530 study drug.
Timepoint [10] 0 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
New Zealand
State/province [2] 0 0
Grafton, Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02442258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Pugatch, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02442258