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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: GS-5737; Drug: Placebo

• Registration Number: NCT01840735
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Study Start: 2013-05
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GS-5737	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.
Placebo	Placebo	The vehicle (placebo) control contains 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline in 4 mL.

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of GS-5737	1 day

Trial Locations

Locations (1)

Compass Research Phase 1, LLC; 🇺🇸 Orlando, Florida, United States