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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2012-06-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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WCK 771

WCK 771 600mg, 800mg, and 1000mg WCK 771 BID. Dosage form : IV Infusion

Group Type EXPERIMENTAL

WCK 771 IV Infusion

Intervention Type DRUG

subjects will receive intravenous infusion of WCK 771

Placebo infusion

Matching Placebo administered as IV infusion

Group Type PLACEBO_COMPARATOR

Placebo IV Infusion

Intervention Type OTHER

subjects will receive matching placebo intravenous infusion

Interventions

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WCK 771 IV Infusion

subjects will receive intravenous infusion of WCK 771

Intervention Type DRUG

Placebo IV Infusion

subjects will receive matching placebo intravenous infusion

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes