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OpenTrials
Completed

NCT Number: NCT02253342

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

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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Key information

Conditions

Intrapulmonary Pharmacokinetics of WCK 2349

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pulmonary Associates, 1112 E. McDowell Rd.

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WCK-2349

Drug

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

Primary outcomes

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

    Time frame: 5 days

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

Secondary outcomes

  1. Steady-state plasma pharmacokinetics of levonadifloxacin

    Time frame: 5 days

    To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349

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

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Collaborators

  • Clinartis

Registry information

Official study title

A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.