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Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects

NCT02453529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-03

No results posted yet for this study

Summary

This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects.

Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873. The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing. Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for determining plasma WCK 4873 concentrations at 48 hours after the third dose.

Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests (including liver function tests), ECG, physical examination and vital sign monitoring. Subjects will discontinue study drug administration in the event of AST/ALT elevation of greater than 3 times the upper limit of normal.

Conditions

  • Healthy

Interventions

DRUG

WCK 4873

Oral tablets

Sponsors & Collaborators

  • Clinartis

    collaborator INDUSTRY

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453529 on ClinicalTrials.gov