Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-9669 tablets
GS-9669 · 1 trial · 1 indication
To evaluate safety and tolerability of escalating multiple oral doses of GS 9669. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs, and 12-lead ECGs at various time points during the study.
To evaluate antiviral activity of GS-9669 against HCV in genotype-1a and 1b (GT1a/b) subjects. This will be evaluated using change from baseline in plasma HCV RNA. Reduction in HCV RNA will be summarized as categorical (as \< 1, ≥ 1 to \<2, ≥ 2 to \<3, or ≥ 3 log10 IU/mL) reduction from baseline.
| Arm | Type | Description |
|---|---|---|
| Multiple-dose, dose-escalation study of GS-9669 | EXPERIMENTAL | Multiple-dose, dose-escalation study of GS-9669, a nonnucleotide NS5B inhibitor of hepatitis C virus (HCV), in subjects with chronic HCV infection. Dosing is planned in up to 7 unique dosing cohorts. Each cohort will be comprised of 10 genotype 1a (Cohorts 1, 2, 3, 4, and 5) or genotype 1b (Cohort 6 and 7), with eight subjects randomized to receive active drug and two subjects randomized to receive placebo per cohort. |
| Name | Type | Description |
|---|---|---|
| GS-9669 tablets | DRUG | - |
| Placebo to Match GS-9669 tablet | DRUG | - |
Inclusion Criteria: * Adult subjects 18-65 years of old, inclusive * Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening. * HCV treatment naïve or PEG-IFN, IFN, and/or RBV experienced (treatment must have ceased at least 3 months prio...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
GS-9669 is an investigational small molecule developed by Gilead Sciences, Inc. for the treatment of chronic hepatitis C virus infection. It was studied in a Phase 1 clinical trial to evaluate its safety, tolerability, pharmacokinetics, and antiviral activity in subjects with chronic hepatitis C. GS-9669 is not approved and remains in clinical development.
GS-9669 was evaluated for the treatment of chronic hepatitis C virus infection. It was tested in a Phase 1 trial to assess its safety, tolerability, pharmacokinetics, and antiviral activity in subjects with chronic hepatitis C. GS-9669 is investigational and has not been approved for any indication.
GS-9669 is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program studying GS-9669 in chronic hepatitis C virus infection.
GS-9669 is in Phase 1 clinical development. It has completed one Phase 1 trial in chronic hepatitis C virus infection. GS-9669 is investigational and has not been approved by the FDA for any indication.
GS-9669 has been studied in one completed Phase 1 trial, NCT01431898, titled Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection. The trial enrolled 82 participants in the United States and Puerto Rico and was uncontrolled, without randomization or double blinding.
Yes, GS-9669 tablets is another name for GS-9669, the investigational small molecule developed by Gilead Sciences, Inc. for chronic hepatitis C virus infection. Both names refer to the same Phase 1 compound.