Study to Evaluate the Effect of Delafloxacin on the Pharmacokinetics of Midazolam in Healthy Subjects

Sponsor

Melinta Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02505997

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

22.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
VA Drug Interactions	Drug: Midazolam Drug: Delafloxacin	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Midazolam/Delafloxacin 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.	Drug: Midazolam Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8. Drug: Delafloxacin Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8

Arm

Intervention/Treatment

Experimental: Midazolam/Delafloxacin

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.

Drug: Midazolam

Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.

Drug: Delafloxacin

Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8

Outcome Measures

Primary Outcome Measures

Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t [Days 1 and 8]
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf [Days 1 and 8]
Midazolam and 1-hydroxymidazolam Plasma PK: Cmax [Days 1 and 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

Melinta Therapeutics, Inc.

Investigators

Study Director: Sue Cammarata, MD, Melinta Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melinta Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT02505997

Other Study ID Numbers:

ML-3341-118

First Posted:

Jul 22, 2015

Last Update Posted:

Dec 16, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Midazolam

Study Results

No Results Posted as of Dec 16, 2016