Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF

NCT ID: NCT01840735

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-08-31

Brief Summary

This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.

Conditions

Cystic Fibrosis

Study Design

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

Study Groups

GS-5737

The GS-5737 85 μg dose is contained in 4 mL of 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline.

Group Type: ACTIVE_COMPARATOR

GS-5737

Intervention Type: DRUG

Placebo

The vehicle (placebo) control contains 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline in 4 mL.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

GS-5737

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males or females, ≥ 18 years of age, at Screening
• Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepithelial potential difference (NPD) test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND 1 or more accompanying clinical features consistent with CF
• FEV1 ≥ 40% and ≤ 90% predicted
• BMI ≥ 19 and ≤ 30 kg/m2
• Clinically stable with no evidence of significant new or acute respiratory symptoms
• Chest radiograph without significant acute findings; or chest radiograph, CT, or MRI obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed
• 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

• Estimated creatinine clearance ≥ 80 mL/min at Screening
• Negative drug tests; including alcohol
• Hepatitis B, C, & HIV Negative
• Surgically sterile or ≥ 12 months post-menopausal
• Non-pregnant females

Exclusion Criteria

• Experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to Screening
• Plasma potassium ≥ 5 mEq/L
• Changes in chronic azithromycin use, bronchodilator (BD), dornase alfa, HS, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to Screening
• History of sputum or throat swab culture yielding Burkholderia species within 2 years of Screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Compass Research Phase 1, LLC

Orlando, Florida, United States

Countries

United States

Other Identifiers

GS-US-234-0117

Identifier Type: -

Identifier Source: org_study_id