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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4 March 2024 |
Main ID: |
NCT04460586 |
Date of registration:
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01/07/2020 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Pharmacokinetics of Omadacycline in Cystic Fibrosis
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Scientific title:
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Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis |
Date of first enrolment:
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July 1, 2021 |
Target sample size:
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9 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT04460586 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Adupa P Rao, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Keck Medicine of USC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age >=18 years
Exclusion Criteria:
- Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs &
symptoms and an acute decline in relative FEV1 of 10% or greater.
- Pregnancy or breastfeeding
- Serious past allergy to a tetracycline antibiotic
- No alcohol, nicotine, or caffeine-containing products during the study period
- Hemoglobin < 8 g/dL
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: Omadacycline Injection [Nuzyra]
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Drug: Omadacycline Oral Tablet [Nuzyra]
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Primary Outcome(s)
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Absolute Bioavailability
[Time Frame: 6 days]
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AUC
[Time Frame: 3 days]
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Cmax
[Time Frame: 3 Days]
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Tmax
[Time Frame: 3 days]
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Secondary ID(s)
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HS-20-00513
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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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