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

NCT02253342 | Completed Phase 1

• 1 other identifier: W-2349-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrapulmonary Pharmacokinetics of WCK 2349

Outcome Measures

Primary Outcomes (1)

• Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)

  Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349

  5 days

Secondary Outcomes (2)

• Steady-state plasma pharmacokinetics of levonadifloxacin

  5 days

• Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign

  14 days

Study Arms (1)

WCK 2349

EXPERIMENTAL

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

Drug: WCK-2349

Interventions

WCK-2349 DRUG

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

WCK 2349

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wockhardt: lead
• Clinartis: collaborator

Study Sites (1)

Pulmonary Associates, 1112 E. McDowell Rd.

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

• Rodvold KA, Gotfried MH, Chugh R, Gupta M, Yeole R, Patel A, Bhatia A. Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02297-17. doi: 10.1128/AAC.02297-17. Print 2018 Mar.

  PMID: 29263070 DERIVED

Study Officials

• Mark H Gotfried, MD

  Pulmonary Associates, PA

  PRINCIPAL INVESTIGATOR

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: September 23, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)