Hepatic ImpairmentPhase 1NCT02245243
Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
A Phase 1 study testing Delafloxacin in people with Hepatic Impairment, run by Melinta Therapeutics, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- 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
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Feb 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.
- Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Hepatically Impaired Subjects Only (Groups A, B, and C):
- -Has a clinical diagnosis of cirrhosis and has been classified as having mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by the Child-Pugh classification system (Section 7.2).
- Healthy Subjects Only (Group D):
- -Must be in good health as determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram [ECG] results, and physical examination findings
Who cannot join
- All Subjects (Groups A through D):
- Has a clinically significant abnormality in past medical history or at the screening physical examination (excluding hepatic impairment and other related stable medical conditions within the hepatically impaired population of subjects) that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically significant and would preclude study participation.
- Has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk (history of cholecystectomy is allowed).
- Has a functioning liver transplant
- Has a history of drug and/or alcohol abuse within 6 months before Screening
Show all 14Show fewer
- Has a history of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent.
- Has donated blood or plasma within 30 days before dosing, or has lost more than 1200 mL of blood within 4 months before the first dose of study drug.
- Has a history of AIDS or subject has positive results for HIV at Screening.
- Hepatically Impaired Subjects Only (Groups A, B, and C):
- Has had clinical exacerbation of liver disease within 14 days before study drug administration (eg, abdominal pain, ascites, nausea, vomiting, anorexia, fever, or worsening of laboratory results related to hepatic function).
- Has evidence of acute viral hepatitis within 1 month before Day -1, has clinically demonstrable massive tense ascites, has evidence of severe or acute renal failure, has active stage 3 or stage 4 encephalopathy.
- Healthy Subjects Only (Group D):
- -Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Melinta 112 Study Site
Miami, Florida, 33136
Melinta 112 Study Site
Orlando, Florida, 32809
About this study
Official title: An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment.
Read the detailed description
pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
- Conditions
- Hepatic Impairment
- Being tested
- Delafloxacin
- Keywords
- Hepatic Impairment, single dose, intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelafloxacinDrug
Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
| Study group | Role | What they receive |
|---|---|---|
| Delafloxacin | Experimental | Single Dose 300 mg IV Receives: Drug: Delafloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
Measured: Baseline through 72 hours post-dose
Secondary outcomes (1)
Safety endpoints: AEs, clinical laboratory results (serum chemistry, coagulation, hematology, and urinalysis), vital sign measurements, 12-lead ECG measurements, and physical examination findings
Measured: Baseline through 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue K Cammarata, MD, Study director, CMO, MelintaTtherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245243
- Sponsor's protocol ID
- ML-3341-112
- Status last verified
- Apr 2015
- First submitted
- 17 Sep 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoover R, Marbury TC, Preston RA, Quintas M, Lawrence LE, Paulson SK, Luke DR, Cammarata SK. Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment. J Clin Pharmacol. 2017 Mar;57(3):328-335. doi: 10.1002/jcph.817. Epub 2016 Oct 14.
PubMed 27570245
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
- ClinicalTrials.gov ID
- NCT02245243
- Acronym / sponsor ID
- ML-3341-112
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, single dose, intravenous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment.
Detailed description
pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delafloxacin | Experimental | Drug: DelafloxacinSingle Dose 300 mg IV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.
- Able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- -Has a clinical diagnosis of cirrhosis and has been classified as having mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by the Child-Pugh classification system (Section 7.2).
- -Must be in good health as determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram [ECG] results, and physical examination findings
Key exclusion criteria (14 listed)
- All Subjects (Groups A through D):
- Has a clinically significant abnormality in past medical history or at the screening physical examination (excluding hepatic impairment and other related stable medical conditions within the hepatically impaired population of subjects) that in the investigator's or sponsor's opinion may place the subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically significant and would preclude study participation.
- Has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk (history of cholecystectomy is allowed).
- Has a functioning liver transplant
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 |
|---|---|---|
| DelafloxacinPlasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz | Drug | Delafloxacin |
Primary outcome
Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
Time frame: Baseline through 72 hours post-dose
1 secondary outcome
Safety endpoints: AEs, clinical laboratory results (serum chemistry, coagulation, hematology, and urinalysis), vital sign measurements, 12-lead ECG measurements, and physical examination findings
Time frame: Baseline through 72 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 27570245Hoover R, Marbury TC, Preston RA, Quintas M, Lawrence LE, Paulson SK, Luke DR, Cammarata SK. Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment. J Clin Pharmacol. 2017 Mar;57(3):328-335. doi: 10.1002/jcph.817. Epub 2016 Oct 14.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
Sue K Cammarata, MD study director
CMO, MelintaTtherapeutics, Inc.
2 sites 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 in people with Hepatic Impairment, run by Melinta Therapeutics, Inc. at 2 sites 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 6 inclusion and 14 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz (time frame: Baseline through 72 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 NCT02245243, 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 30 Apr 2015.