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

Gilead Sciences

Status and phase

Terminated

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Cystic Fibrosis

Treatments

Drug: GS-5737

Study type

Interventional

Funder types

Industry

Identifiers

NCT01793649

GS-US-234-0103

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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