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Pharmacokinetics of Omadacycline in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omadacycline Injection [Nuzyra]

Omadacycline Oral Tablet [Nuzyra]

About this trial

This is an interventional other trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omadacycline IV followed by PO

Arm Description

Omadacycline 100mg IV, Omadacycline 300 mg tablet

Outcomes

Primary Outcome Measures

Cmax

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

Tmax

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

AUC

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

Absolute Bioavailability

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04460586

First Posted

July 1, 2020

Last Updated

November 7, 2022

Sponsor

Paul Beringer

Collaborators

Paratek Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT04460586

Brief Title

Pharmacokinetics of Omadacycline in Cystic Fibrosis

Official Title

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul Beringer

Collaborators

Paratek Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential source of lung infection in CF patients. As omadacycline demonstrates antimicrobial activity against a number of pathogens in CF, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with CF in the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with CF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omadacycline IV followed by PO

Arm Type

Experimental

Arm Description

Omadacycline 100mg IV, Omadacycline 300 mg tablet

Intervention Type

Drug

Intervention Name(s)

Omadacycline Injection [Nuzyra]

Intervention Description

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Intervention Type

Drug

Intervention Name(s)

Omadacycline Oral Tablet [Nuzyra]

Intervention Description

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Primary Outcome Measure Information:

Title

Cmax

Description

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

Time Frame

3 Days

Title

Tmax

Description

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

Time Frame

3 days

Title

AUC

Description

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

Time Frame

3 days

Title

Absolute Bioavailability

Description

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

Time Frame

6 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul M. Beringer, PharmD

Phone

323-442-1402

beringer@usc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adupa P Rao, M.D.

Organizational Affiliation

Keck Medicine of USC

Official's Role

Study Director

Facility Information:

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90089

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul M. Beringer, PharmD

Phone

323-442-1402

beringer@usc.edu

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of Omadacycline in Cystic Fibrosis

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