Status:
TERMINATED
A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults
Lead Sponsor:
Melinta Therapeutics, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06612255
Start Date
June 3 2024
End Date
September 11 2024
Last Update
September 26 2025
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS