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

NCT ID: NCT01793649

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Cystic Fibrosis; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cross-Over Sequence 1

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

Group Type: EXPERIMENTAL

GS-5737

Intervention Type: DRUG

A single dose of GS-5737 in 2.8% saline

Cross-Over Sequence 2

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

Group Type: EXPERIMENTAL

GS-5737

Intervention Type: DRUG

A single dose of GS-5737 in 2.8% saline

Interventions

GS-5737

A single dose of GS-5737 in 2.8% saline

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Bresnik, M.D.

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Investigational Site

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

GS-US-234-0103

Identifier Type: -

Identifier Source: org_study_id