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Pharmacokinetics of Omadacycline in Cystic Fibrosis

NCT04460586 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-08

Study results available
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Summary

The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    collaborator INDUSTRY

  • Paul Beringer

    lead OTHER

Principal Investigators

  • Adupa P Rao, M.D. · Keck Medicine of USC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-12-01
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460586 on ClinicalTrials.gov