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Trial record 7 of 3092 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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Chronic Obstructive Pulmonary Disease Drug: GS-5737 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cross-Over Sequence 1
85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded)
Drug: GS-5737
A single dose of GS-5737 in 2.8% saline

Experimental: Cross-Over Sequence 2
2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded)
Drug: GS-5737
A single dose of GS-5737 in 2.8% saline




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793649


Locations
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United States, North Carolina
Investigational Site
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Mark Bresnik, M.D. Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01793649     History of Changes
Other Study ID Numbers: GS-US-234-0103
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Gilead Sciences:
Respiratory health
Cystic Fibrosis
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
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Fibrosis
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cystic Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases