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

Primary Purpose

Cystic Fibrosis, Chronic Obstructive Pulmonary Disease

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GS-5737

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Respiratory health, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cross-Over Sequence 1

Cross-Over Sequence 2

Arm Description

85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded)

2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded)

Outcomes

Primary Outcome Measures

Area under the curve of MCC from Whole Lung Compartment

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

Area under the curve of MCC from Central and Peripheral Lung

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).

Full Information

NCT ID

NCT01793649

First Posted

February 14, 2013

Last Updated

March 19, 2014

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01793649

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Study Start Date

October 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Chronic Obstructive Pulmonary Disease

Keywords

Respiratory health, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cross-Over Sequence 1

Arm Type

Experimental

Arm Description

85 μg GS-5737 in 2.8% saline or 2.8% saline alone (blinded)

Arm Title

Cross-Over Sequence 2

Arm Type

Experimental

Arm Description

2.8% saline alone or 85 μg GS-5737 in 2.8% saline (blinded)

Intervention Type

Drug

Intervention Name(s)

GS-5737

Intervention Description

A single dose of GS-5737 in 2.8% saline

Primary Outcome Measure Information:

Title

Area under the curve of MCC from Whole Lung Compartment

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Area under the curve of MCC from Central and Peripheral Lung

Description

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).

Time Frame

4 weeks or duration of study

Other Pre-specified Outcome Measures:

Title

Safety and tolerability of GS-5737

Description

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.

Time Frame

4 weeks or duration of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Bresnik, M.D.

Organizational Affiliation

Gilead Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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