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

NCT02453529 | Completed Phase 1

• 1 other identifier: W-4873-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

plasma concentration; pulmonary concentration

Outcome Measures

Primary Outcomes (1)

• • Epithelial lining fluid (ELF) and alveolar macrophage (AM) will be used to assess the concentrations of oral WCK 4873 in healthy adult subjects

  48 hrs per dose

Secondary Outcomes (2)

• • Safety and tolerability of oral WCK 4873 in healthy adult subjects as measure by safety lab assesments, ECGs, physical examinations and AEs captured.

  8 weeks

• • Pharmacokinetic (PK) profile of multiple doses (800 mg) of WCK 4873 in healthy adult subjects

  48 hrs last dose

Study Arms (1)

WCK 4873

EXPERIMENTAL

Oral tablets

Drug: WCK 4873

Interventions

WCK 4873 DRUG

Oral tablets

WCK 4873

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI) 18.5 and 30 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive).
• Medical history without any major pathology as judged by the Principal Investigator.
• Resting supine blood pressure 100-139 (systolic) or 60-89 (diastolic) mm Hg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations 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 alcohol breath test or urine drug screen test at screening or confinement.
• Positive testing for HIV, Hepatitis B or Hepatitis C.
• Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with pulmonary lavage.

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, Friedland HD, Bhatia A. Comparison of Plasma and Intrapulmonary Concentrations of Nafithromycin (WCK 4873) in Healthy Adult Subjects. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e01096-17. doi: 10.1128/AAC.01096-17. Print 2017 Sep.

  PMID: 28696231 DERIVED

MeSH Terms

Interventions

nafithromycin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: May 25, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

US (1)