A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
1 other identifier
interventional
5
1 country
1
Brief Summary
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2017
CompletedSeptember 5, 2017
September 1, 2017
2 months
February 15, 2017
September 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Day 1 through Day 15
Secondary Outcomes (2)
Relative change from baseline through Day 8 in percent predicted FEV1
Screening and Day 1 through Day 8
Change from baseline through Day 8 in clinical laboratory tests
Screening and Day 1 through Day 8
Study Arms (3)
SPX-101 Low Dose
EXPERIMENTALInhalation Solution twice daily for 7 days.
SPX-101 Mid Dose
EXPERIMENTALInhalation Solution twice daily for 7 days.
SPX-101 High Dose
EXPERIMENTALInhalation Solution twice daily for 7 days.
Interventions
Inhalation solution twice daily for 7 days.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CF
- FEV1 ≥ 40% predicted normal
- Stable CF lung disease
- Non-pregnant, non-lactating females
You may not qualify if:
- Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
- Has received an investigational drug within the past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Related Publications (1)
Couroux P, Farias P, Rizvi L, Griffin K, Hudson C, Crowder T, Tarran R, Tullis E. First clinical trials of novel ENaC targeting therapy, SPX-101, in healthy volunteers and adults with cystic fibrosis. Pulm Pharmacol Ther. 2019 Oct;58:101819. doi: 10.1016/j.pupt.2019.101819. Epub 2019 Jul 11.
PMID: 31302339DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Tullis, MD
Unity Health Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 17, 2017
Study Start
May 31, 2017
Primary Completion
August 2, 2017
Study Completion
August 2, 2017
Last Updated
September 5, 2017
Record last verified: 2017-09