Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771

Wockhardt36 enrolled

Overview

The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Bioavailability

Interventions

WCK 771 IV InfusionDRUG

subjects will receive intravenous infusion of WCK 771

Placebo IV InfusionOTHER

subjects will receive matching placebo intravenous infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 * Use of any prescription drug within 14 days prior to start of the study (check-in) and nonprescription drug within 7 days prior to start of study (check-in)

Locations (1)

PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200

Austin, Texas, United States

Outcomes

Primary Outcomes

To evaluate the safety & tolerability of multiple doses of WCK 771

By monitoring the adverse events reported

Time frame: Day 12

To evaluate the pharmacokinetics of multiple doses of WCK 771

Measuring Cmax Maximum observed plasma concentration.

Time frame: Day 5

Data from ClinicalTrials.gov

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