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

NCT01793649 | Terminated Phase 1

• 1 other identifier: GS-US-234-0103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

Respiratory health; Cystic Fibrosis; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Area under the curve of MCC from Central and Peripheral Lung

  4 weeks or duration of study

Other Outcomes (1)

• Safety and tolerability of GS-5737

  4 weeks or duration of study

Study Arms (2)

Cross-Over Sequence 1

EXPERIMENTAL

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

Drug: GS-5737

Cross-Over Sequence 2

EXPERIMENTAL

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

Drug: GS-5737

Interventions

GS-5737 DRUG

A single dose of GS-5737 in 2.8% saline

Cross-Over Sequence 1; Cross-Over Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Bresnik, M.D.

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

US (1)