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This is a single center, open-label, Phase 1 study to determine the mass balance of of GS-5806 following administration of a single, oral dose of radiolabeled [14C]-GS-5806 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5806 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine and fecal recovery of total [14C]-radioactivity | The primary outcome measure of this study is the urine and fecal recovery of total [14C]-radioactivity. | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of [14C]-GS-5806 | The secondary endpoint measure is the urine and fecal recovery of [14C]-GS-5806 and, where measurable, its metabolite(s). | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and blood concentration and PK parameters - Radioactivity | Secondary endpoint measures include the plasma and blood concentration and PK parameters of total [14C]-radioactivity, and the plasma to blood ratio of [14C]-radioactivity. | 22 days |
| Plasma and blood concentration and PK parameters - Non-radiolabeled |
Inclusion Criteria:
Exclusion Criteria:
Smokers, use of nicotine or nicotine-containing products within 90 days prior to the first dose of study drug. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥200 ng/mL at screening.
A positive HIV-1 antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody test result.
Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to study dosing.
Have participated in studies using radiomaterials or ionizing radiations or have been otherwise exposed to significant diagnostic (excluding dental X-rays), therapeutic, or occupational radiation.
Current alcohol or substance abuse as judged by the Investigator or as determined by a positive alcohol or drug test at screening or baseline visit.
Have poor venous access and are unable to donate blood.
Have donated blood within 56 days of study dosing or plasma within 7 days of study dosing.
Have been vaccinated within 90 days of study dosing or, for the influenza vaccine, within 14 days prior to study dosing.
Have taken any prescription medications or over-the-counter medications, including herbal products, or medications that affect gastric pH (ie, antacids, H2RAs, and/or proton pump inhibitors) within 28 days of commencing study drug dosing with the exception of vitamins, acetaminophen, and ibuprofen.
Have taken any systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies).
Evidence of any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Toback, M.D. | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000591241 | presatovir |
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Secondary endpoint measures include the plasma concentration and PK parameters of non-radiolabeled GS-5806 and, where measurable, its metabolite(s). |
| 22 Days |
| Plasma and blood concentration and PK parameters - [14C]-GS-5806 | Secondary endpoint measures include the plasma concentration and PK parameters of [14C]-GS-5806, and where measurable, its metabolite(s). | 22 Days |
| D014777 | Virus Diseases |
| D007239 | Infections |