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

NCT01840735 | Completed Phase 1

• 1 other identifier: GS-US-234-0117
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

CF; Cystic Fibrosis; PK

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of GS-5737

  1 day

Study Arms (2)

GS-5737

ACTIVE COMPARATOR

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.

Drug: GS-5737

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GS-5737 DRUG

GS-5737

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 =
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Compass Research Phase 1, LLC

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Design

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

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

US (1)