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Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Phase 1 trial testing Velpatasvir in Hepatitis C Virus in 19 participants. Completed in 9 June 2014.
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 16 December 2013 |
| Primary completion | 9 June 2014 |
| Estimated completion | 9 June 2014 |
| Sites | 5 locations across New Zealand, United States |
Gilead Sciences — full company profile →
Adults 18 to 79, any sex, with Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 5597.8 | ± 1749.18 |
| Severe Renal Impairment | 7971.7 | ± 2531.09 |
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 5651.6 | ± 1763.12 |
| Severe Renal Impairment | 8108.3 | ± 2628.18 |
Cmax is defined as the maximum observed plasma concentration of drug.
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 702.7 | ± 197.20 |
| Severe Renal Impairment | 732.4 | ± 176.19 |
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 0 | |
| Severe Renal Impairment | 20 |
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 33.3 | |
| Severe Renal Impairment | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 0 | |
| Severe Renal Impairment | 30 |
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 0 | |
| Severe Renal Impairment | 30 |
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 0 | |
| Severe Renal Impairment | 10 |
Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 0.29 | ± 0.012 |
| Severe Renal Impairment | 0.29 | ± 0.012 |
| Group | Value | 95% CI |
|---|---|---|
| Normal Renal Function | 99.71 | ± 0.012 |
| Severe Renal Impairment | 99.71 | ± 0.012 |
Time frame: First dose date plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Normal Renal Function | Severe Renal Impairment |
|---|---|---|---|
| Vessel puncture site haemorrhage | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
Data from ClinicalTrials.gov NCT02002767 adverse events section.
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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