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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01793649
• Other study ID #: GS-US-234-0103
• Status: Terminated
• Phase: Phase 1
• First received: February 14, 2013
• Last updated: March 19, 2014
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Cystic Fibrosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GS-5737
A single dose of GS-5737 in 2.8% saline

Locations

Country	Name	City	State
United States	Investigational Site	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of GS-5737	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.	4 weeks or duration of study	Yes
Primary	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.	4 weeks	No
Secondary	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).	4 weeks or duration of study	No