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

NCT02505997 | Completed Phase 1

• 1 other identifier: ML-3341-118
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

VA Drug Interactions

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Midazolam; Drug: Delafloxacin

Interventions

Midazolam DRUG

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

Midazolam/Delafloxacin

Delafloxacin DRUG

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

Midazolam/Delafloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Publications (1)

• 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.

  PMID: 28495029 DERIVED

MeSH Terms

Interventions

Midazolam; delafloxacin

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sue Cammarata, MD

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 22, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)