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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01801293
First received: February 26, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
RSV Infection
Drug: GS-5806
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of GS-5806

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Urine and fecal recovery of total [14C]-radioactivity [ Time Frame: 22 days ] [ Designated as safety issue: No ]
    The primary outcome measure of this study is the urine and fecal recovery of total [14C]-radioactivity.


Secondary Outcome Measures:
  • Recovery of [14C]-GS-5806 [ Time Frame: 22 days ] [ Designated as safety issue: No ]
    The secondary endpoint measure is the urine and fecal recovery of [14C]-GS-5806 and, where measurable, its metabolite(s).


Other Outcome Measures:
  • Plasma and blood concentration and PK parameters - Radioactivity [ Time Frame: 22 days ] [ Designated as safety issue: No ]
    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.

  • Plasma and blood concentration and PK parameters - Non-radiolabeled [ Time Frame: 22 Days ] [ Designated as safety issue: No ]
    Secondary endpoint measures include the plasma concentration and PK parameters of non-radiolabeled GS-5806 and, where measurable, its metabolite(s).

  • Plasma and blood concentration and PK parameters - [14C]-GS-5806 [ Time Frame: 22 Days ] [ Designated as safety issue: No ]
    Secondary endpoint measures include the plasma concentration and PK parameters of [14C]-GS-5806, and where measurable, its metabolite(s).


Enrollment: 8
Study Start Date: March 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm
One-time single dose of 50 mg radiolabeled GS-5806 administered orally in 3 capsules in the morning.
Drug: GS-5806

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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:

    1. Clinically significant ECG abnormalities.
    2. Syncope, palpitations, or unexplained dizziness.
    3. Liver disease (including known Gilbert's Disease) or clinical evidence of liver injury or hepatic synthetic dysfunction.
    4. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (>6 months) medical treatment.
    5. History of medical or surgical treatment that permanently alters the gastric conditions (eg, gastrectomy).
    6. Significant drug sensitivity or drug allergy.
    7. Known hypersensitivity to sulfa drugs.
    8. Known hypersensitivity to the study drug, metabolites or formulation excipients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801293

Locations
United States, Wisconsin
Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Seth Toback, M.D. Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01801293     History of Changes
Other Study ID Numbers: GS-US-218-0109
Study First Received: February 26, 2013
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
RSV infection

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014