Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2878175 · 2 trials · 1 indication
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...
GSK2878175 is an investigational small molecule being developed for the treatment of chronic hepatitis C. It is currently in Phase 1 clinical development and has been studied in healthy volunteers and in patients with chronic hepatitis C infection.
GSK2878175 is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The drug is in Phase 1 clinical development for chronic hepatitis C.
GSK2878175 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in subjects with chronic hepatitis C. The drug is investigational and has not been approved by regulatory authorities.
GSK2878175 has been studied in two completed Phase 1 trials. NCT01879462 evaluated safety, tolerability, and pharmacokinetics of single and repeat escalating doses in healthy subjects. NCT02014571 assessed safety, pharmacokinetics, and antiviral activity of repeat doses in subjects with chronic hepatitis C.
GSK2878175 is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its antiviral activity against chronic hepatitis C infection.