Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000341-23 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Renal Function | Experimental | Participants will receive a single dose of voxilaprevir on Day 1. |
|
| Severe Renal Impairment | Experimental | Participants will receive a single dose of voxilaprevir on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voxilaprevir | Drug | 100 mg tablet administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast | 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. | 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 |
| PK Parameter of Voxilaprevir: AUCinf | 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. | 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 postdose |
| PK Parameter of Voxilaprevir: Cmax | Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals. | 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 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities | The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized. | First dose date to Day 31 |
Not provided
Key Inclusion Criteria:
All individuals:
For individuals with severe renal impairment:
Key Exclusion Criteria:
All individuals:
For individuals with severe renal impairment:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director, MD, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States | ||
| Texas Liver Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, Wei H, Sajwani K, Klein G, Gane E, Robson R. The effect of renal or hepatic impairment on the pharmacokinetics of GS-9857, a pangenotypic HCV NS3/4A protease inhibitor. The International Liver Congress; 2016; Barcelona, Spain. |
Not provided
Not provided
39 participants were screened.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1. |
| FG001 | Normal Renal Function | Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1. |
| BG001 | Normal Renal Function | Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 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 |
|
First dose date up to 31 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Renal Impairment | Participants with severe renal impairment received a single dose of voxilaprevir 100 mg tablet orally on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619503 | voxilaprevir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| San Antonio |
| Texas |
| 78215 |
| United States |
| APEX GmbH | München | 81241 | Germany |
| Christchurch Clinical Studies Trust Ltd | Christchurch | 8011 | New Zealand |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Creatinine Clearance | Mean | Standard Deviation | mL/min |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| Normal Renal Function |
Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1. |
|
|
|
| Primary | PK Parameter of Voxilaprevir: AUCinf | 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. | Participants in the PK Analysis Set were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 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 postdose |
|
|
|
|
| Primary | PK Parameter of Voxilaprevir: Cmax | Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals. | Participants in the PK Analysis Set were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 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 postdose |
|
|
|
|
| Secondary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities | The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date to Day 31 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Normal Renal Function | Participants with matched normal renal function received a single dose voxilaprevir of 100 mg tablet orally on Day 1. | 0 | 10 | 0 | 10 | 5 | 10 |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
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:
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |