Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

NCT03534622 | Completed Phase 1 FDA Drug

• 1 other identifier: ML-3341-119
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the steady-state intrapulmonary disposition of delafloxacin in healthy adult participants.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (6)

• Delafloxacin plasma PK:Tmax

  Day 4

• Delafloxacin plasma PK: Cmax

  Day 4

• Delafloxacin plasma PK: AUCτ

  Day 4

• Delafloxacin plasma PK: AUC0-t

  Day 4

• Delafloxacin plasma PK: AUCinf

  Day 4

• Delafloxacin plasma PK: T1/2

  Day 4

Study Arms (1)

Delafloxacin

EXPERIMENTAL

Dosing will be initiated on Day 1. All participants will receive 300-mg delafloxacin as a 1-hour intravenous infusion every 12 hours (± 15 minutes) for a total of 7 doses.

Drug: Delafloxacin

Interventions

Delafloxacin DRUG

In this study, thirty subjects who meet the entry criteria will be assigned to 1 of 5 groups (A, B,C, D, or E) to receive 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days

Delafloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant has no clinically important abnormal physical findings that could interfere with the conduct of the study.
• Participant has no clinically significant laboratory abnormalities.
• Participant has normal (or abnormal but not clinically significant) ECG measurements.
• Participant has BMI between 18.0 and ≤30.0 kg/m2, inclusive, or if outside the range, considered not clinically significant.
• Participant has normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. Blood pressure and pulse rate will be measured after the participant has been in a sitting position for 5 minutes. For this study, normal blood pressure is defined as 100 to 140 mmHg systolic and 50 to 90 mmHg diastolic, inclusive. Normal pulse rate is defined as 50 to 90 beats per minute, inclusive.
• Participant is willing and able to abstain from alcohol, caffeine, and methylxanthine containing beverages or food. Alcohol, caffeine, and methylxanthine consumption will be prohibited within 96 hours before Check-in and throughout the entire study throughout Follow-up.
• Participant is able to communicate well with the investigator and comply with the requirements of the entire study.
• Participant provides written informed consent to participate as indicated by a signature on the informed consent form (ICF).
• Participant agrees to use an adequate method of contraception during the study and for 30 days after the final dose. Female partners of male subjects should also use an additional reliable method of contraception. Adequate methods of contraception for the participant and partner include, but are not limited to, condoms with spermicide gel,diaphragm with spermicide gel, hormonal or nonhormonal intrauterine device, surgical sterilization, vasectomy, oral contraceptive pill, depot progesterone injections, or abstinence. If abstinence is indicated as the method of contraception, the participant must have been abstinent for 6 weeks before enrollment in the study. If a participant is usually not sexually active but becomes active, the participant and his or her partner should use one of the listed contraceptive methods.
• Female subjects of childbearing potential must be nonpregnant, nonlactating, and have a negative serum human chorionic gonadotropin pregnancy test at Screening and a negative urine pregnancy test at Check-In.

You may not qualify if:

• Participant has received any investigational drug within 30 days before administration of the first dose of the study drug (6 months for biologic therapies) or 5 half-lives of the investigational drug, if known, whichever time period is longer.
• Participant has received delafloxacin previously.
• Participant is a female who is pregnant or breastfeeding. Pregnancy status will be confirmed by serum assay for qualitative human chorionic gonadotropin at Screening and a urine assay performed at Check-in.
• Participant has a positive test result for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, or cotinine, at Screening or Check-in.
• Participant has a positive screening test for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus antibodies.
• Participant has any surgical or medical condition that, in the judgment of the investigator,might interfere with the absorption, distribution, metabolism, or excretion of the study drug.
• Participant has used an oral or IV antibiotic within 3 months of administration of the first dose of the study drug.
• Participant has routinely or chronically used more than 1 g of acetaminophen daily.
• Participant has performed strenuous activity, sunbathing, and/or contact sports within 96 hours (4 days) before Check-in on Day -1. The participant should abstain from these activities for the duration of the study.
• Participant has donated or lost greater than 400 mL of blood in the 30 days before administration of the first dose of study drug.
• Participant is unable to be venipunctured or tolerate venous access as determined by the investigator or designee.
• Participant has a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) or drug reaction (angioedema, atopic dermatitis, or uticaria), including medical history of significant hypersensitivity or allergic reaction to quinolones or beta-lactam antibiotics, lidocaine, or similar compounds. Participants with a history of seasonal allergies are allowed unless the allergy is active or has required treatment within the past 30 days.
• Participant has a history of clinically significant, clinically relevant hematologic, renal, hepatic, bronchopulmonary (including history of chronic respiratory disorders, anatomy not conducive for bronchoscopy), neurological, psychiatric, metabolic, endocrine disorder (eg, diabetes, thyroid disease) or cardiovascular disease, in the opinion of the investigator.
• Subject has a history of clinically significant GI disease, or gastroenteritis (vomiting or diarrhea) or any history of GI bleeding (excluding bleeding from hemorrhoids), and/or surgery that would result in the subject's inability to absorb or metabolize the study drug (eg, gastrectomy, gastric bypass, cholecystectomy).
• Participant has a history of any drug or alcohol abuse in the past 2 years, or alcohol consumption greater than 21 units per week in males and 14 units per week in females. A unit of alcohol is equivalent to 1 can of beer, 1 glass of wine, or the equivalent of 1 alcoholic drink. Alcohol consumption will be prohibited within 96 hours before Check-in on Day -1 and throughout the entire study until Follow-up.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

• Horcajada JP, Salata RA, Alvarez-Sala R, Nitu FM, Lawrence L, Quintas M, Cheng CY, Cammarata S; DEFINE-CABP Study Group. A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP). Open Forum Infect Dis. 2019 Dec 5;7(1):ofz514. doi: 10.1093/ofid/ofz514. eCollection 2020 Jan.

  PMID: 31988972 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

delafloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sue K Cammarata, MD

  CMO, MelintaTherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 23, 2018
• Study Start: April 30, 2018
• Primary Completion: July 19, 2018
• Study Completion: July 27, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)