A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of GS-5806

NCT01801293 | Completed Phase 1

• 1 other identifier: GS-US-218-0109
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RSV Infection

Keywords

RSV infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Recovery of [14C]-GS-5806

  22 days

Other Outcomes (3)

• Plasma and blood concentration and PK parameters - Radioactivity

  22 days

• Plasma and blood concentration and PK parameters - Non-radiolabeled

  22 Days

• Plasma and blood concentration and PK parameters - [14C]-GS-5806

  22 Days

Study Arms (1)

Intervention Arm

EXPERIMENTAL

One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning.

Drug: GS-5806

Interventions

GS-5806 DRUG

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a calculated body mass index (BMI) from 19 to 30 kg/m2 at study screening.
• In the opinion of the Investigator, subjects must be in good health based upon medical history, physical examination (including vital signs), and screening and baseline laboratory evaluations (hematology, chemistry, and urinalysis must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance).
• Agree to utilize a highly effective method of contraception during heterosexual intercourse from baseline throughout the study period and for 90 days following discontinuation of study drug.
• Refrain from sperm donation from Day -1 through completion of the study and continuing for at least 90 days from the date of last dose of study drug.
• Have a creatinine clearance (CLcr) \> 80 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation.
• Anticipated, regular, average bowel movement of 1-2 per day.

You may not qualify if:

• 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:
• Clinically significant ECG abnormalities.
• Syncope, palpitations, or unexplained dizziness.
• Liver disease (including known Gilbert's Disease) or clinical evidence of liver injury or hepatic synthetic dysfunction.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

presatovir

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Seth Toback, M.D.

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

US (1)