Pharmacokinetics of Omadacycline in Cystic Fibrosis

NCT04460586 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HS-20-00513
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• Cmax

  To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.

  3 Days

• Tmax

  To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.

  3 days

• AUC

  To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration.

  3 days

• Absolute Bioavailability

  To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.

  6 days

Study Arms (1)

Omadacycline IV followed by PO

EXPERIMENTAL

Omadacycline 100mg IV, Omadacycline 300 mg tablet

Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet [Nuzyra]

Interventions

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.

Omadacycline IV followed by PO

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 IV followed by PO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF based on positive sweat chloride or known CF mutation
• Age \>=18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Beringer: lead
• Paratek Pharmaceuticals Inc: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (1)

• Sanders M, Hong E, Chung PS, Rao AP, Beringer P. Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis. Clin Pharmacokinet. 2024 Dec;63(12):1701-1709. doi: 10.1007/s40262-024-01440-w. Epub 2024 Nov 24.

  PMID: 39581957 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

omadacycline

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Dr. Paul Beringer
• Organization: University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences

beringer@usc.edu

3234421402

Study Officials

• Adupa P Rao, M.D.

  Keck Medicine of USC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-05

Locations

US (1)