At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 9 enrolled
Drug / intervention
Omadacycline Injection [Nuzyra] +1 moredrug
Likely dose
Omadacycline Injection [Nuzyra] 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis
In Brief
A Phase 4 clinical trial evaluating Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet [Nuzyra] for Cystic Fibrosis. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsParatek Pharmaceuticals Inc
Timeline
Phase 4CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartJul 2021
Primary CompletionDec 2023
Study CompletionDec 2023
TodayJul 2026
First PostedJul 7, 2020
Enrollment StartJul 1, 2021
Primary CompletionDec 1, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.0 years ago
Interventions
Omadacycline Injection [Nuzyra]drug
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
Omadacycline Oral Tablet [Nuzyra]drug
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.