Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: WCK 2349 Oral; Other: Placebo Oral

• Registration Number: NCT04874324
• Lead Sponsor: Wockhardt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-17
• Primary Completion: 2011-05-04
• Study Completion: 2011-06-25
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WCK 2349	WCK 2349 Oral	WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral
Placebo	Placebo Oral	Matching Placebo administered as Oral

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of multiple doses of WCK 2349	5 days	Measuring Cmax Maximum observed plasma concentration.
To evaluate the safety & tolerability of multiple doses of WCK 2349	12 days	By monitoring the adverse events reported