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

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-5737 in Subjects With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840735
• Other study ID #: GS-US-234-0117
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2013
• Last updated: August 8, 2014
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• GS-5737

• Placebo

Locations

Country	Name	City	State
United States	Compass Research Phase 1, LLC	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) of GS-5737		1 day	Yes