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PneumoniaPhase 1NCT03534622

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

A Phase 1 study testing Delafloxacin in people with Pneumonia, run by Melinta Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pneumonia
What is being tested?
Delafloxacin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Apr 2018to 27 Jul 2018
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • Participant has used any medication (prescription or over-the-counter [OTC], including health supplements and herbal remedies, with the exception of acetaminophen (as described in Exclusion Criterion 9) within 2 weeks (4 weeks for enzyme inducers including St John's wort [Hypericum perforatum]) or 5 half-lives (whichever is longer) before the first dose of 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.
  • Participant currently smokes or has smoked in the past year or uses or has used nicotine or nicotine containing products in the past 6 months.
  • Participant has had any major surgery within 4 weeks of study drug administration.
  • Participant has a history of malignancy within the past 5 years other than past history of localized or surgical removal of focal basal cell skin cancer, cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy), or by hysterectomy.
  • Participant has any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants in the study.
  • Participation in another clinical study within 30 days of enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pulmonary Associates

    Phoenix, Arizona, 85006

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

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

Read the detailed description

This study will evaluate the safety and pharmacokinetics (PK) of delafloxacin in healthy adult participants by assessing the intrapulmonary disposition in adults receiving 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days.

Conditions
Pneumonia
Being tested
Delafloxacin
Medical subject headings
Pneumonia

What participants receive

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

  • DelafloxacinDrug

    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

Study groups in NCT03534622
Study groupRoleWhat they receive
DelafloxacinExperimentalDosing 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.
Receives: Drug: Delafloxacin

What is being measured

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

  1. Delafloxacin plasma PK:Tmax

    Measured: Day 4

  2. Delafloxacin plasma PK: Cmax

    Measured: Day 4

  3. Delafloxacin plasma PK: AUCτ

    Measured: Day 4

  4. Delafloxacin plasma PK: AUC0-t

    Measured: Day 4

  5. Delafloxacin plasma PK: AUCinf

    Measured: Day 4

  6. Delafloxacin plasma PK: T1/2

    Measured: Day 4

Timeline

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

  1. First posted23 May 2018
  2. Study start30 Apr 2018
  3. Primary completion19 Jul 2018
  4. Study completion27 Jul 2018

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03534622
Sponsor's protocol ID
ML-3341-119
Status last verified
Aug 2018
First submitted
18 Apr 2018
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31988972

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Delafloxacin in people with Pneumonia, run by Melinta Therapeutics, Inc. at 1 site in United States.

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 10 inclusion and 21 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: finished, as of the sponsor's last update on 15 Aug 2018. 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 States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Delafloxacin plasma PK:Tmax (time frame: Day 4). The study lists 6 primary outcomes in all. 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 NCT03534622, which also lists 1 linked publication.

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 15 Aug 2018.

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