Safety, tolerability and pharmacokinetics study of WCK 2349 (in single doses) in healthy male volunteer.

Phase 1

Completed

• Registration Number: CTRI/2009/091/000377
• Lead Sponsor: Wockhardt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

Healthy males between 18 and 45 years of age (both inclusive) living in and around the City (investigational site).

Having a Body Mass Index (BMI) between 18.5 and 24.9 (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, ECG, EEG and X-ray recordings

Be able to communicate effectively with the study personnel.

Be able to sign the Informed Consent Form

Able to comply with the study related procedures

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs
Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal Investigator
Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria
&#61558;A recent history of alcoholism (<2 years) or of moderate (180mL/day) alcohol use, or consumption of alcohol within 48h of receiving study medication
&#61558;Smokers, who smoke more than 10 cigarettes / day or those who can not refrain from smoking during study period.
&#61558;The presence of clinically significant abnormal laboratory values during screening
&#61558;Use of recreational drugs or history of drug addiction or testing positive in pre-study drug scan
&#61558;History of psychiatric disorders
&#61558;A history of difficulty with donating blood
&#61558;Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication (Note: Incase the blood loss was &#8804; 200 mL, subject may be enrolled 60 days after the blood donation)
&#61558;A positive hepatitis screen including hepatitis B surface antigen, HCV antigen and anti-HAV antibodies
&#61558;A positive test result for HIV antibody and/or syphilis
&#61558;The receipt of an investigational drug or product, or participation in a drug research study within a period of 90 days prior to the first dose of study medication (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study)
&#61558;An unusual diet (e.g. low-sodium for high blood pressure), for whatever reason, for four weeks prior to receiving the study medication and throughout the subjects? participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety & tolerability of single escalated doses of oral WCK 2349 in healthy, adult, male, human subjects. <br/ ><br> <br/ ><br>To evaluate the pharmacokinetics of single escalated doses of oral WCK 2349 in healthy, adult, male, human subjects. <br/ ><br> <br/ ><br>Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI