HealthyPhase 1NCT06612255

A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults

A Phase 1 study testing Delafloxacin and Delafloxacin Powder in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Delafloxacin and Delafloxacin Powder
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Jun 2024to 11 Sep 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must agree to adhere to the protocol-specified contraception requirements.
Body mass index of 18.0 to 32.0 kilograms (kg)/meter squared as measured at screening.
Weight ≥50 kg at screening.

Who cannot join

Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.
History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.
Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold.
Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.
Participants who do not agree to eat a high-fat breakfast.
Note: Other inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

Conditions: Healthy
Being tested: Delafloxacin, Delafloxacin Powder
Keywords: Delafloxacin, Baxdela, BARDA, Bioavailability, Taste-masked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelafloxacinDrug
Also called Baxdela, Quofeni, Delabaxi, RX-3341
Delafloxacin tablet
Delafloxacin PowderDrug
Delafloxacin powder for oral suspension formulation

Study groups in NCT06612255
Study group	Role	What they receive
Regimen A then B: Delafloxacin Tablet then Powder	Experimental	Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B). Receives: Drug: Delafloxacin; Drug: Delafloxacin Powder
Regimen B then A: Delafloxacin Powder then Tablet	Experimental	Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A). Receives: Drug: Delafloxacin; Drug: Delafloxacin Powder
Regimen C: Delafloxacin Powder	Experimental	Participants will receive delafloxacin powder in fasted or fed states. Receives: Drug: Delafloxacin Powder
Regimen D (Optional): Delafloxacin Powder	Experimental	Participants will receive delafloxacin powder in fasted or fed states. Receives: Drug: Delafloxacin Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms*hour/milliliter (ng*h/mL).
Measured: Pre-dose on Day 1, up to 24 hours post-dose

Secondary outcomes (3)

Maximum Observed Concentration (Cmax) of Delafloxacin Powder
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL).
Measured: Pre-dose on Day 1, up to 48 hours post-dose
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder
Blood samples were obtained at protocol-specified timepoints. Results reported as ng*h/mL.
Measured: Pre-dose on Day 1, up to 48 hours post-dose
Number of Participants Experiencing Treatment-emergent Adverse Events
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.
Measured: Day 1 through Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202411 Sep 2024

First posted25 Sep 2024
Study start3 Jun 2024
Primary completion11 Sep 2024
Study completion11 Sep 2024

Why it stopped: Study goals not met

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06612255
Sponsor's protocol ID: ML-DEL-101-3727-1
Other IDs: 75A50123C00022, 1009679, QSC300553
Status last verified: Sep 2026
First submitted: 23 Sep 2024
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects
ClinicalTrials.gov ID: NCT06612255
Acronym / sponsor ID: ML-DEL-101-3727-1
Conditions: Healthy
Keywords: Delafloxacin, Baxdela, BARDA, Bioavailability, Taste-masked
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study goals not met
Enrolment: 16 participants (actual)
Lead sponsor: Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 3 Jun 2024 (actual)
Primary completion: 11 Sep 2024 (actual)
Study completion: 11 Sep 2024 (actual)
First posted: 25 Sep 2024 (actual)
Results: Posted 26 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Regimen A then B: Delafloxacin Tablet then Powder	Experimental	Drug: Delafloxacin, Drug: Delafloxacin PowderParticipants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
Regimen B then A: Delafloxacin Powder then Tablet	Experimental	Drug: Delafloxacin, Drug: Delafloxacin PowderParticipants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
Regimen C: Delafloxacin Powder	Experimental	Drug: Delafloxacin PowderParticipants will receive delafloxacin powder in fasted or fed states.
Regimen D (Optional): Delafloxacin Powder	Experimental	Drug: Delafloxacin PowderParticipants will receive delafloxacin powder in fasted or fed states.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Must agree to adhere to the protocol-specified contraception requirements.
Body mass index of 18.0 to 32.0 kilograms (kg)/meter squared as measured at screening.
Weight ≥50 kg at screening.

Key exclusion criteria (6 listed)

Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.
History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.
Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold.
Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.
Participants who do not agree to eat a high-fat breakfast.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DelafloxacinAlso: Baxdela, Quofeni, Delabaxi, RX-3341Delafloxacin tablet	Drug	Regimen A then B: Delafloxacin Tablet then Powder, Regimen B then A: Delafloxacin Powder then Tablet
Delafloxacin PowderDelafloxacin powder for oral suspension formulation	Drug	Regimen A then B: Delafloxacin Tablet then Powder, Regimen B then A: Delafloxacin Powder then Tablet, Regimen C: Delafloxacin Powder, Regimen D (Optional): Delafloxacin Powder

Primary outcome

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
Time frame: Pre-dose on Day 1, up to 24 hours post-dose
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms*hour/milliliter (ng*h/mL).

3 secondary outcomes

Maximum Observed Concentration (Cmax) of Delafloxacin Powder
Time frame: Pre-dose on Day 1, up to 48 hours post-dose
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder
Time frame: Pre-dose on Day 1, up to 48 hours post-dose
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 6

Results and safety

Results posted to the registry on 26 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen A Then B: Delafloxacin Tablet Then Powder	8	8
Regimen B Then A: Delafloxacin Powder Then Tablet	8	8

Primary outcome: 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

Time frame: Pre-dose on Day 1, up to 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Regimen A: Delafloxacin Tablet n = 16	Regimen B: Delafloxacin Powder n = 16
Value	15700 (26.9)	8120 (33.9)

Regimen A: Delafloxacin Tablet vs Regimen B: Delafloxacin Powder: Fixed Effect Analysis: 51.68 (90% CI 45.71 to 58.43)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen A: Delafloxacin Tablet	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Regimen B: Delafloxacin Powder	0 of 16 (0%)	5 of 16 (31.3%)	0 of 16

Limitations and caveats (from the sponsor): Following interim review of the pharmacokinetics and safety data, the decision was made to terminate the study early owing to lower-than-expected exposure levels for delafloxacin powder for oral suspension.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Information study director

Melinta Therapeutics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Delafloxacin and Delafloxacin Powder in people with Healthy, run by Melinta Therapeutics, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Pre-dose on Day 1, up to 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06612255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.