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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01840735

Enrollment

Registered

2013-04-26

Start date

2013-05-31

Completion date

2013-08-31

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

CF, Cystic Fibrosis, PK

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.

Interventions

DRUGGS-5737

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax) of GS-5737	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026