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

NCT ID: NCT02505997

Last Updated: 2016-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

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

Delafloxacin

Intervention Type: DRUG

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

Interventions

Midazolam

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

Intervention Type: DRUG

Delafloxacin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue Cammarata, MD

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

PPD Development, LP

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28495029 (View on PubMed)

Other Identifiers

ML-3341-118

Identifier Type: -

Identifier Source: org_study_id