Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03258424 |
Date of registration:
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18/08/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy
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Scientific title:
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A Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis. |
Date of first enrolment:
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July 28, 2017 |
Target sample size:
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15 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03258424 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed diagnosis of CF.
- Stable on Kalydeco dosing for both label indication and per label dosing for a minimum
of 3 months at the time of randomization
- Forced expiratory volume in 1 second (FEV1) 40-90% predicted.
- Non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for
the duration of the study.
Exclusion Criteria:
- Participation in another clinical trial or treatment with an investigational agent
within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.
- History of cancer within the past five years (excluding cervical CIS with curative
therapy for at least one year prior to screening and non-melanoma skin cancer).
- History of organ transplantation.
- Any sinopulmonary infection or CF exacerbation requiring a change or addition of
medication (including antibiotics) within 1 month of Study Day 1 or any other
clinically significant infection as determined by the investigator within 1 month of
Day 1.
- History of alcohol or drug abuse or dependence within 12 months of screening as
determined by the Investigator.
- Male and female of child-bearing potential, unless they are using highly effective
methods of contraception during participation in the clinical study and for 4 weeks
after termination from study.
- Pregnant or nursing women.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: PTI-428
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Drug: Placebo
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Primary Outcome(s)
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Safety and tolerability as assessed by adverse events, safety labs, electrocardiograms (ECGs), physical examinations, and vital signs
[Time Frame: Baseline through Day 21]
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Secondary Outcome(s)
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Tmax of multiple oral doses
[Time Frame: Baseline through Day 14]
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AUC0-t of multiple oral doses
[Time Frame: Baseline through Day 14]
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Cmax of multiple oral doses
[Time Frame: Baseline through Day 14]
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t1/2 of multiple oral doses
[Time Frame: Baseline through Day 14]
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Secondary ID(s)
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PTI-428-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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