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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840735
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: GS-5737 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: 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.
Drug: GS-5737
Placebo Comparator: Placebo
The vehicle (placebo) control contains 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline in 4 mL.
Drug: Placebo



Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of GS-5737 [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840735


Locations
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United States, Florida
Compass Research Phase 1, LLC
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01840735     History of Changes
Other Study ID Numbers: GS-US-234-0117
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by Gilead Sciences:
CF
Cystic Fibrosis
PK
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases