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

Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: WCK 2349 Oral; Other: Placebo Oral

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: WCK 2349; 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; 1 dose given orally twice daily at 12 hourly interval for five days.
PLACEBO_COMPARATOR: Placebo; Matching Placebo administered as Oral	Other: Placebo Oral; Subjects will receive matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wockhardt

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2011
• Primary Completion (ACTUAL): May 4, 2011
• Study Completion (ACTUAL): June 25, 2011

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (ACTUAL): May 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: WCK 2349/ P-I/ MD/ 08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No