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Clinical trial

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

ID
Name
HS-20-00513
Description
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Trial arms
Trial start
2021-07-01
Estimated PCD
2023-12-01
Trial end
2023-12-31
Status
Completed
Phase
Early phase I
Treatment
Omadacycline Injection [Nuzyra]
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
Arms:
Omadacycline IV followed by PO
Omadacycline Oral Tablet [Nuzyra]
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
Arms:
Omadacycline IV followed by PO
Size
9
Primary endpoint
Cmax
3 Days
Tmax
3 days
AUC
3 days
Absolute Bioavailability
6 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}
Updated at
2024-02-22

1 organization

1 product

1 indication

Organization
Paul Beringer
Product
Omadacycline
Indication
Cystic Fibrosis