Trial Outcomes & Findings for Pharmacokinetics of Omadacycline in Cystic Fibrosis (NCT NCT04460586)
NCT ID: NCT04460586
Last Updated: 2026-05-08
Results Overview
To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
3 Days
Results posted on
2026-05-08
Participant Flow
Participant milestones
| Measure |
Omadacycline IV Followed by PO
Participants received a single 100 mg intravenous dose of omadacycline (Nuzyra) administered over 30 minutes, followed by a 7-day washout period and a single 300 mg oral dose of omadacycline (Nuzyra).
|
|---|---|
|
OMC 100 mg IV + PK (72 h)
STARTED
|
9
|
|
OMC 100 mg IV + PK (72 h)
COMPLETED
|
9
|
|
OMC 100 mg IV + PK (72 h)
NOT COMPLETED
|
0
|
|
Washout (7 days)
STARTED
|
9
|
|
Washout (7 days)
COMPLETED
|
9
|
|
Washout (7 days)
NOT COMPLETED
|
0
|
|
OMC 300 mg PO + PK (72 h)
STARTED
|
9
|
|
OMC 300 mg PO + PK (72 h)
COMPLETED
|
9
|
|
OMC 300 mg PO + PK (72 h)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Omadacycline in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Omadacycline IV Followed by PO
n=9 Participants
Omadacycline 100mg IV, Omadacycline 300 mg tablet
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.
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.
|
|---|---|
|
Age, Continuous
|
39.11 years
STANDARD_DEVIATION 11.37 • n=41 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
5 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=41 Participants
|
|
Body Mass Index (BMI)
|
25.55 kg/m^2
STANDARD_DEVIATION 5.12 • n=41 Participants
|
|
Forced expiratory volume in 1 second (FEV1)
|
71.3 percent (%) predicted
STANDARD_DEVIATION 14.2 • n=41 Participants
|
PRIMARY outcome
Timeframe: 3 DaysTo assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Outcome measures
| Measure |
Omadacycline IV Followed by PO
n=9 Participants
Omadacycline 100mg IV, Omadacycline 300 mg tablet
|
|---|---|
|
Cmax
Omadacycline IV
|
0.733 mg/L
Standard Deviation 0.226
|
|
Cmax
Omadacycline Oral
|
0.595 mg/L
Standard Deviation 0.240
|
PRIMARY outcome
Timeframe: 3 daysTo assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
Outcome measures
| Measure |
Omadacycline IV Followed by PO
n=9 Participants
Omadacycline 100mg IV, Omadacycline 300 mg tablet
|
|---|---|
|
Tmax
Omadacycline IV
|
NA hr
Standard Deviation NA
Tmax is not applicable (NA) for the intravenous formulation, as the drug is administered directly into systemic circulation and peak concentration occurs at or near the time of infusion completion.
|
|
Tmax
Omadacycline Oral
|
2.333 hr
Standard Deviation 1.225
|
PRIMARY outcome
Timeframe: 3 daysTo assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration.
Outcome measures
| Measure |
Omadacycline IV Followed by PO
n=9 Participants
Omadacycline 100mg IV, Omadacycline 300 mg tablet
|
|---|---|
|
AUC
Omadacycline IV
|
9.234 h*mg/L
Standard Deviation 2.968
|
|
AUC
Omadacycline Oral
|
8.902 h*mg/L
Standard Deviation 3.102
|
PRIMARY outcome
Timeframe: 6 daysTo determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.
Outcome measures
| Measure |
Omadacycline IV Followed by PO
n=9 Participants
Omadacycline 100mg IV, Omadacycline 300 mg tablet
|
|---|---|
|
Absolute Bioavailability
Omadacycline IV
|
NA percent (%)
Standard Deviation NA
Absolute bioavailability is not applicable (NA) for the intravenous formulation, since the drug is administered directly into systemic circulation (100% availability by definition).
|
|
Absolute Bioavailability
Omadacycline Oral
|
34.8 percent (%)
Standard Deviation 15.3
|
Adverse Events
Omadacycline 100 mg IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Omadacycline 300 mg PO
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omadacycline 100 mg IV
n=9 participants at risk
Single 100 mg intravenous dose of omadacycline administered over 30 minutes, with pharmacokinetic sampling over 72 hours.
|
Omadacycline 300 mg PO
n=9 participants at risk
Single 300 mg oral dose of omadacycline administered under fasting conditions following a 7-day washout from the IV dose, with pharmacokinetic sampling over 72 hours.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
0.00%
0/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
11.1%
1/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
0.00%
0/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
11.1%
1/9 • Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
|
Additional Information
Dr. Paul Beringer
University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences
Phone: 3234421402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place