VA Drug InteractionsPhase 1NCT02505997
Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects
A Phase 1 study testing Midazolam and Delafloxacin in people with VA Drug Interactions, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- VA Drug Interactions
- What is being tested?
- Midazolam and Delafloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically important abnormal physical findings.
- No clinically significant laboratory abnormalities.
- Normal (or abnormal but not clinically significant) ECG measurements.
- Body mass index between 18.0 and 32.0 kg/m2.
- Normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. methylxanthine-containing beverages or food
- Non-smoker
Who cannot join
- Received any investigational drug within 8 weeks before administration of the first dose of the study drug
- Female who is pregnant, has a positive pregnancy test, or is breastfeeding.
- Positive test result for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, methylenedioxymethamphetamine, cotinine, or alcohol in urine at Screening or Day -1.
- Positive screening test for hepatitis B surface antigen, hepatitis C, and/or human immunodeficiency virus antibodies.
- Any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Used any medication (prescription or over-the-counter, including health supplements and herbal remedies, with the exception of acetaminophen, as defined in exclusion number 8) within 2 weeks (4 weeks for drugs or substances known to inhibit or induce CYP enzymes and/or P-gp including St. John's wort [Hypericum perforatum]) or 5 half-lives (whichever is longer) before the first dose of study drug.
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- Used an oral or IV antibiotic within 4 weeks of administration of the first dose of the study drug.
- Routinely or chronically used more than 2 g of acetaminophen daily.
- Performed strenuous activity, sunbathing, and/or contact sports within 96 hours (4 days) before entry into the clinical study site on Day -1, and for the duration of the study.
- Donated or lost greater than 400 mL of blood in the 30 days before administration of the first dose of the study drug.
- History of clinically significant GI disease, or gastroenteritis (vomiting or diarrhea) or any history of GI bleeding (excluding bleeding from hemorrhoids)
- History of any significant drug allergy
- History of any drug or alcohol abuse in the past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects
The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.
Read the detailed description
This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.
- Conditions
- VA Drug Interactions
- Being tested
- Midazolam, Delafloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.
DelafloxacinDrug
Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8
| Study group | Role | What they receive |
|---|---|---|
| Midazolam/Delafloxacin | Experimental | Each subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8. Receives: Drug: Midazolam; Drug: Delafloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t
Measured: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf
Measured: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: Cmax
Measured: Days 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 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 VA Drug InteractionsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue Cammarata, MD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505997
- Sponsor's protocol ID
- ML-3341-118
- Status last verified
- Dec 2016
- First submitted
- 23 Jun 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Paulson SK, Wood-Horrall RN, Hoover R, Quintas M, Lawrence LE, Cammarata SK. The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin. Clin Ther. 2017 Jun;39(6):1182-1190. doi: 10.1016/j.clinthera.2017.04.009. Epub 2017 May 9.
PubMed 28495029
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02505997
- Acronym / sponsor ID
- ML-3341-118
- Conditions
- VA Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Jul 2015 (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 effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.
Detailed description
This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam/Delafloxacin | Experimental | Drug: Midazolam, Drug: DelafloxacinEach subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No clinically important abnormal physical findings.
- No clinically significant laboratory abnormalities.
- Normal (or abnormal but not clinically significant) ECG measurements.
- Body mass index between 18.0 and 32.0 kg/m2.
- Normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. methylxanthine-containing beverages or food
Key exclusion criteria (13 listed)
- Received any investigational drug within 8 weeks before administration of the first dose of the study drug
- Female who is pregnant, has a positive pregnancy test, or is breastfeeding.
- Positive test result for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, methylenedioxymethamphetamine, cotinine, or alcohol in urine at Screening or Day -1.
- Positive screening test for hepatitis B surface antigen, hepatitis C, and/or human immunodeficiency virus antibodies.
- Any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
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 |
|---|---|---|
| MidazolamSingle 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8. | Drug | Midazolam/Delafloxacin |
| DelafloxacinOral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8 | Drug | Midazolam/Delafloxacin |
Primary outcome
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t
Time frame: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf
Time frame: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: Cmax
Time frame: Days 1 and 8
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 16 Dec 2016.
- Derived from this study: PubMed 28495029Paulson SK, Wood-Horrall RN, Hoover R, Quintas M, Lawrence LE, Cammarata SK. The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin. Clin Ther. 2017 Jun;39(6):1182-1190. doi: 10.1016/j.clinthera.2017.04.009. Epub 2017 May 9.
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 Cammarata, MD 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 Midazolam and Delafloxacin in people with VA Drug Interactions, 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 6 inclusion and 13 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 16 Dec 2016. 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?
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t (time frame: Days 1 and 8). The study lists 3 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 NCT02505997, 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 16 Dec 2016.