Trial Outcomes & Findings for Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment (NCT NCT02402452)
NCT ID: NCT02402452
Last Updated: 2020-03-20
Results Overview
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
0 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Results posted on
2020-03-20
Participant Flow
Participants were enrolled at study sites in the United States, Germany, and New Zealand. The first participant was screened on 05 May 2015. The last study visit occurred on 28 September 2015.
39 participants were screened.
Participant milestones
| Measure |
Severe Renal Impairment
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
Baseline characteristics by cohort
| Measure |
Severe Renal Impairment
n=10 Participants
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 Participants
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
55 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
57 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Creatinine Clearance
|
21.2 mL/min
STANDARD_DEVIATION 5.75 • n=5 Participants
|
114.8 mL/min
STANDARD_DEVIATION 15.31 • n=7 Participants
|
68.0 mL/min
STANDARD_DEVIATION 49.34 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.2 kg/m^2
STANDARD_DEVIATION 5.54 • n=5 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 4.08 • n=7 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdosePopulation: PK Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory for the corresponding analyte.
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
Outcome measures
| Measure |
Severe Renal Impairment
n=10 Participants
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 Participants
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
|
662.7 h*ng/mL
Interval 361.4 to 1215.3
|
383.3 h*ng/mL
Interval 252.3 to 582.3
|
PRIMARY outcome
Timeframe: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
Outcome measures
| Measure |
Severe Renal Impairment
n=10 Participants
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 Participants
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
PK Parameter of Voxilaprevir: AUCinf
|
772.1 h*ng/mL
Interval 426.3 to 1398.6
|
450.8 h*ng/mL
Interval 295.7 to 687.4
|
PRIMARY outcome
Timeframe: 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.
Outcome measures
| Measure |
Severe Renal Impairment
n=10 Participants
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 Participants
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
PK Parameter of Voxilaprevir: Cmax
|
49.2 ng/mL
Interval 26.6 to 91.1
|
33.9 ng/mL
Interval 23.8 to 48.2
|
SECONDARY outcome
Timeframe: First dose date to Day 31Population: Participants in the Safety Analysis Set were analyzed.
The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.
Outcome measures
| Measure |
Severe Renal Impairment
n=10 Participants
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 Participants
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities
Any TEAE
|
20 percentage of participants
|
50 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities
Any treatment-emergent laboratory abnormality
|
70 percentage of participants
|
30 percentage of participants
|
Adverse Events
Severe Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Normal Renal Function
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Severe Renal Impairment
n=10 participants at risk
Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1.
|
Normal Renal Function
n=10 participants at risk
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
20.0%
2/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
10.0%
1/10 • First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER