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

Phase 1

Completed

• Conditions: Intrapulmonary Pharmacokinetics of WCK 2349
• Interventions: Drug: WCK-2349

• Registration Number: NCT02253342
• Lead Sponsor: Wockhardt

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-10-01
• Primary Completion: 2014-12
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)	5 days	Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349

Secondary Outcome Measures

Name	Time	Method
Steady-state plasma pharmacokinetics of levonadifloxacin	5 days	To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349
Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign	14 days

Trial Locations

Locations (1)

Pulmonary Associates, 1112 E. McDowell Rd.; 🇺🇸 Phoenix, Arizona, United States