Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02014571 | Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C. | PHASE1 | COMPLETED | 37 | — | — | Dec 26, 2013 | Jan 15, 2015 | Jul 24, 2018 | 1 | Puerto Rico |
| NCT01879462 | A First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single & Repeat Escalating Doses of GSK2878175 in Healthy Subjects | PHASE1 | COMPLETED | 47 | — | — | Jun 14, 2013 | Jan 10, 2014 | Jul 24, 2018 | 1 | Australia |
AEs will be collected from the start of Study Treatment and until 14 days post last-dose (at follow up).
Absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs (blood pressure \[BP\], FSH/Estradiol (Women), Urine β-hCG (Women) temperature, and heart rate), 12 LED ECG, and Holter monitoring, ECG intervals, ECG rhythm, and telemetry will be measured. Telemetry is the continuous monitoring of a subject's heart rate and rhythm from a remote location. Pulmonary function testing includes a group of tests that measure how well the lung is functioning.
PK parameters include: AUC (0-24), Tmax, Cmax,C24, t1/2, tlag, CL/F for Day 1
PK parameters include: AUC (0-t), Ct, Cmax, tmax, t1/2, CL/F for Day 2.
HCV RNA viral load reduction from baseline at the 24 hr, 48 hr, and 72 hr timepoints during dosing of GSK2878175 in HCV subjects
HCV RNA change from baseline to nadir (maximum change) in CHC subjects.
Time course of HCV viral load at baseline, during, and after dosing with GSK2878175.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Eight subjects will be randomized to receive either 10 mg of GSK2878175 active treatment (4 HCV genotype 1a \[GT1a\] and 2 HCV genotype 1b \[GT1b\]) or matching placebo (1 GT1a and 1 GT1b) daily for 2 days fasted. |
| Cohort B | EXPERIMENTAL | Eight subjects will be randomized to receive either 30 mg of GSK2878175 active treatment (4 GT1a and 2 GT1b) or matching placebo (1 GT1a and 1 GT1b) daily for 2 days fasted. |
| Cohort C | EXPERIMENTAL | Eight subjects will be randomized to receive either GSK2878175 active treatment (4 GT1a and 2 GT1b) or matching placebo (1 GT1a and 1 GT1b) daily for 2 days fasted. |
| Cohort D | EXPERIMENTAL | Twenty subjects will be randomized to receive either 60 mg of GSK2878175 active treatment (6 GT2, 6 GT3, 3 GT4) or matching placebo (2 GT2, 2 GT3, 1 GT4). |
| Cohort E | EXPERIMENTAL | Subjects in this cohort will receive placebo and GSK2878175 100 mg single dose or placebo for 7 days in fasted state, (with 1:4 ratio of placebo to active treatment). |
| Cohort F | EXPERIMENTAL | Subjects in this cohort will receive placebo and GSK2878175 200 mg single dose or placebo for 7 days in fasted state, (with 1:4 ratio of placebo to active treatment). |
| Name | Type | Description |
|---|---|---|
| GSK2878175 | DRUG | Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose. |
| Placebo | DRUG | Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose visually matching GSK2878175. |
Inclusion Criteria: * Has chronic genotype 1 (subtypes 1a or 1b) or genotype 2 or genotype 3 or genotype 4 (as assessed by VERSANT® HCV Genotype assay 2.0 (LiPA); VERSANT is a registered trademark of the Siemens Healthcare company.) HCV infection documented by at least 1 measurement of serum HCV RN...