The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

NCT ID: NCT03926962

Last Updated: 2019-04-25

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-14

Study Completion Date

2013-07-13

Brief Summary

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This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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WCK 4873

100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)

Group Type EXPERIMENTAL

WCK 4873

Intervention Type DRUG

100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)

Placebo

Visually matching placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Visually matching placebo

Interventions

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WCK 4873

100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)

Intervention Type DRUG

Placebo Oral Tablet

Visually matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI : 18-30 kg/m2 (Body Mass Index \[BMI\] \[kg/m2\] = Body weight \[kg\] Height2 \[m2\])
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology

Exclusion Criteria

* Evidence of clinically relevant pathology
* Mental handicap
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
* Smoking within 60 days prior to drug administration and through the follow-up visit
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wockhardt

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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W 4873 01

Identifier Type: -

Identifier Source: org_study_id

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