Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.

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Detailed Description

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Conditions

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Intrapulmonary Pharmacokinetics of WCK 2349

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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WCK 2349

Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1

Group Type EXPERIMENTAL

WCK-2349

Intervention Type DRUG

Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1

Interventions

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WCK-2349

Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
* Medical history without any major pathology as judged by the Principal Investigator.

Exclusion Criteria

* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive urine drug/alcohol testing at screening or confinement.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.
* Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
* Known hypersensitivity to quinolones/fluoroquinolones.
* History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes