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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
GS-9669 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended for patients with chronic Hepatitis C virus infection.
GS-9669 is a small molecule antiviral drug. Its specific molecular target has not been disclosed in available information. The drug is being studied for its antiviral activity against chronic Hepatitis C virus infection.
GS-9669 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical research to evaluate the safety and efficacy of GS-9669 in patients with Hepatitis C.
GS-9669 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is still in early-stage clinical trials to assess its safety, tolerability, and antiviral activity.
GS-9669 has been studied in one completed Phase 1 clinical trial, identified as NCT01431898. This trial evaluated the safety, tolerability, pharmacokinetics, and antiviral activity of GS-9669 in 82 subjects with chronic Hepatitis C virus infection. The study was conducted in the United States and Puerto Rico.
GS-9669 is the primary name for this investigational drug. No alternative names have been reported in available clinical trial information. The drug is identified by its compound designation GS-9669 in clinical research records.