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Trial record 7 of 3118 for:    Area Under Curve AND Healthy

A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01793649
Recruitment Status : Terminated
First Posted : February 15, 2013
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date March 20, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
Area under the curve of MCC from Whole Lung Compartment [ Time Frame: 4 weeks ]
The primary endpoint of this study will be the calculated area under the curve of MCC from the whole lung compartment, assessed through 60 minutes post isotope dosing (AUC-60min), which will provide a description of the MCC curve.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01793649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2013)
Area under the curve of MCC from Central and Peripheral Lung [ Time Frame: 4 weeks or duration of study ]
This outcome measure will be the calculated area under the cuve of MCC from the central and peripheral lung assessed through 60 minutes post isotope dosing (AUC60min).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2013)
Safety and tolerability of GS-5737 [ Time Frame: 4 weeks or duration of study ]
Adverse events, airway reactivity, pulse oximetry, physical examination, and clinical laboratory test findings, urine and plasma potassium levels, 12-lead ECG abnormalities and interval measurements, and vital sign measurements will be used to assess this outcome measure.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy Subjects
Brief Summary This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Drug: GS-5737
A single dose of GS-5737 in 2.8% saline
Study Arms  ICMJE
  • Experimental: Cross-Over Sequence 1
    85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded)
    Intervention: Drug: GS-5737
  • Experimental: Cross-Over Sequence 2
    2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded)
    Intervention: Drug: GS-5737
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 18, 2013)
7
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2013)
12
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) from ≥ 19 to ≤ 30 kg/m2
  • Normal ECG, with no history or evidence of myocardial infarction, QT prolongation, or ventricular arrhythmias
  • Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR)
  • History of lifetime smoking < 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to Screening
  • Negative screening tests for drugs of abuse (including alcohol)
  • Hepatitis B (HBV) surface antigen negative
  • Hepatitis C (HCV) antibody negative
  • HIV-1, 2 antibody negative
  • Male subjects who are sexually active must be willing to use highly effective contraception from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
  • Male subjects must refrain from sperm donation from the Baseline Visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug
  • Females of childbearing potential must have a negative serum pregnancy test
  • Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study treatment and for 30 days following the last dose of study drug

Exclusion Criteria:

  • Female subjects who are pregnant or lactating
  • History of anaphylactic reaction to any drug
  • Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing
  • Presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months
  • Have donated blood within 56 days of study dosing
  • Presence or history of any pulmonary diseases (ie, asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis, interstitial lung disease)
  • Major surgery within 6 months of Screening
  • Experienced symptoms of recent acute upper or lower respiratory tract infection requiring treatment within the 2 weeks prior to Screening
  • Have had any radiation in the past year that would cause the subject exceed recommended limits by participating in this study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01793649
Other Study ID Numbers  ICMJE GS-US-234-0103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Bresnik, M.D. Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP