Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-5806 · 2 trials · 2 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| GS-5806 | DRUG | GS-5806, powder for oral solution |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy male or female * Between 18 to 45 years old * Body Mass Index of 18 to 33 kg/m2 Exclusion Criteria: * Acute or chronic medical illness * Positive for Human Immunodeficiency Virus, Hepatitis B or C * Nose or nasopharynx abnormalities * Abnormal lung function
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.
GS-5806 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD.
GS-5806 is in Phase 1 clinical development. It has completed a Phase 1 study evaluating its pharmacokinetics, metabolism, and excretion, as well as a Phase 2 study in healthy volunteers infected with RSV.
GS-5806 has completed two clinical trials: NCT01756482, a Phase 2 study in healthy volunteers infected with RSV, and NCT01801293, a Phase 1 study evaluating its pharmacokinetics, metabolism, and excretion.
GS-5806 is also known as presatovir. It is an investigational small molecule antiviral being studied for the treatment of Respiratory Syncytial Virus infections.