NCT04874324

Brief Summary

The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2011

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

April 30, 2021

Last Update Submit

November 28, 2022

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • To evaluate the safety & tolerability of multiple doses of WCK 2349

    By monitoring the adverse events reported

    12 days

  • To evaluate the pharmacokinetics of multiple doses of WCK 2349

    Measuring Cmax Maximum observed plasma concentration.

    5 days

Study Arms (2)

WCK 2349

EXPERIMENTAL

WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral

Drug: WCK 2349 Oral

Placebo

PLACEBO COMPARATOR

Matching Placebo administered as Oral

Other: Placebo Oral

Interventions

WCK 2349 OralDRUG

1 dose given orally twice daily at 12 hourly interval for five days.

WCK 2349
Placebo OralOTHER

Subjects will receive matching placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be healthy males or non-pregnant females
  • Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2
  • Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings.
  • Should test negative for drugs of abuse and urine alcohol test.

You may not qualify if:

  • Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
  • Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

levonadifloxacin

Study Officials

  • Ashima Bhatia, MD

    Wockhardt Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

March 17, 2011

Primary Completion

May 4, 2011

Study Completion

June 25, 2011

Last Updated

December 1, 2022

Record last verified: 2022-11