Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Presatovir
GS-5806 · 6 trials · 5 indications
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee: * Primary RSV lower respiratory tract infection (LRTI) * Secondary bacterial LRTI * LRTI due to unusual pathogens * Lower respiratory tract complication of unknown etiology
The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.
Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.
The primary outcome measure of this study is the urine and fecal recovery of total \[14C\]-radioactivity.
| Arm | Type | Description |
|---|---|---|
| Presatovir | EXPERIMENTAL | Presatovir 200 mg (4 x 50 mg) on Day 1, followed by 100 mg (2 x 50 mg) from Day 2 to Day 14 |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets for a total of 14 days |
| Presatovir placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of presatovir placebo. |
| GS-5806 | EXPERIMENTAL | GS-5806, powder for oral solution |
| Sugar powder for oral solution in juice | PLACEBO_COMPARATOR | Sugar powder for oral solution |
| Intervention Arm | EXPERIMENTAL | One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning. |
| Name | Type | Description |
|---|---|---|
| Presatovir | DRUG | Tablets administered orally or via nasogastric (NG) tube once daily |
| Placebo | DRUG | Tablets administered orally or via NG tube once daily |
| Presatovir placebo | DRUG | Presatovir placebo tablets administered orally |
| GS-5806 | DRUG | GS-5806, powder for oral solution |
Key Inclusion Criteria: * Males and females ≥18 years of age who have received a LT (single or double) or heart/lung transplant \> 90 days prior to Screening * Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract samp...
GS-5806 is an investigational small molecule being developed for the treatment of Respiratory Syncytial Virus (RSV) infections. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety and efficacy against RSV infection.
GS-5806 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
GS-5806 is in Phase 1 clinical development. Two clinical trials have been completed: one Phase 1 study evaluating pharmacokinetics, metabolism, and excretion, and one Phase 2 study assessing safety and efficacy in healthy volunteers infected with RSV. The drug remains investigational.
GS-5806 has completed two clinical trials. NCT01756482 was a Phase 2 study in 140 healthy volunteers infected with RSV in the United Kingdom. NCT01801293 was a Phase 1 study in 8 healthy male volunteers in the United States evaluating pharmacokinetics, metabolism, and excretion.
GS-5806 is a distinct investigational small molecule developed by Gilead Sciences for Respiratory Syncytial Virus infections. No alternative names have been associated with this drug in clinical trial records. It is being studied separately from other RSV therapeutics.