Trial Outcomes & Findings for A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults (NCT NCT06612255)
NCT ID: NCT06612255
Last Updated: 2025-09-26
Results Overview
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Pre-dose on Day 1, up to 24 hours post-dose
Results posted on
2025-09-26
Participant Flow
During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, data were only collected for Regimen A and Regimen B.
Participant milestones
| Measure |
Regimen A Then B: Delafloxacin Tablet Then Powder
Participants received delafloxacin tablet in a fasted state (Regimen A), followed by delafloxacin powder in a fasted state (Regimen B).
|
Regimen B Then A: Delafloxacin Powder Then Tablet
Participants received delafloxacin powder in a fasted state (Regimen B), followed by delafloxacin tablet in a fasted state (Regimen A).
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
Receive at Least 1 Dose of Study Drug
|
8
|
8
|
|
First Intervention
COMPLETED
|
8
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Days)
STARTED
|
8
|
8
|
|
Washout (4 Days)
COMPLETED
|
8
|
8
|
|
Washout (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
8
|
|
Second Intervention
Receive at Least 1 Dose of Study Drug
|
8
|
8
|
|
Second Intervention
COMPLETED
|
8
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults
Baseline characteristics by cohort
| Measure |
Regimen A Then B: Delafloxacin Tablet Then Powder
n=8 Participants
Participants received delafloxacin tablet in a fasted state (Regimen A), followed by delafloxacin powder in a fasted state (Regimen B).
|
Regimen B Then A: Delafloxacin Powder Then Tablet
n=8 Participants
Participants received delafloxacin powder in a fasted state (Regimen B), followed by delafloxacin tablet in a fasted state (Regimen A).
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1, up to 24 hours post-dosePopulation: Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints.
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
Outcome measures
| Measure |
Regimen A: Delafloxacin Tablet
n=16 Participants
Participants received delafloxacin tablet in a fasted state.
|
Regimen B: Delafloxacin Powder
n=16 Participants
Participants received delafloxacin powder in a fasted state.
|
|---|---|---|
|
Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet
|
15700 ng*h/mL
Geometric Coefficient of Variation 26.9
|
8120 ng*h/mL
Geometric Coefficient of Variation 33.9
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, up to 48 hours post-dosePopulation: Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints.
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL).
Outcome measures
| Measure |
Regimen A: Delafloxacin Tablet
n=16 Participants
Participants received delafloxacin tablet in a fasted state.
|
Regimen B: Delafloxacin Powder
Participants received delafloxacin powder in a fasted state.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Delafloxacin Powder
|
1850 ng/mL
Geometric Coefficient of Variation 33.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, up to 48 hours post-dosePopulation: Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints.
Blood samples were obtained at protocol-specified timepoints. Results reported as ng\*h/mL.
Outcome measures
| Measure |
Regimen A: Delafloxacin Tablet
n=16 Participants
Participants received delafloxacin tablet in a fasted state.
|
Regimen B: Delafloxacin Powder
Participants received delafloxacin powder in a fasted state.
|
|---|---|---|
|
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder
|
8450 ng*h/mL
Geometric Coefficient of Variation 33.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 6Population: Safety Analysis Set: all participants who received any amount of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant that occurred either before dosing or once an investigational medicinal product (IMP) had been administered, including occurrences which were not necessarily caused by or related to that product. Treatment-emergent adverse events were AEs that commenced during/after the first administration of IMP or commenced before first administration of IMP, that is, a pre-dose AE or existing medical condition, but worsened in intensity during exposure to IMP. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Regimen A: Delafloxacin Tablet
n=16 Participants
Participants received delafloxacin tablet in a fasted state.
|
Regimen B: Delafloxacin Powder
n=16 Participants
Participants received delafloxacin powder in a fasted state.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-emergent Adverse Events
|
2 Participants
|
5 Participants
|
Adverse Events
Regimen A: Delafloxacin Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Regimen B: Delafloxacin Powder
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regimen A: Delafloxacin Tablet
n=16 participants at risk
Participants received delafloxacin tablet in a fasted state.
|
Regimen B: Delafloxacin Powder
n=16 participants at risk
Participants received delafloxacin powder in a fasted state.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
12.5%
2/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
12.5%
2/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
General disorders
Catheter site pain
|
6.2%
1/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
6.2%
1/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
6.2%
1/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
6.2%
1/16 • Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, safety data were only collected for Regimen A and Regimen B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place