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

April 24, 2019 updated by: Wockhardt

Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Drug: 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)
PLACEBO_COMPARATOR: Placebo
Visually matching placebo
Drug: Placebo Oral Tablet
Visually matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing incidence of treatment emergent AEs
Time Frame: Day 18
Incidence of treatment emergent AEs, abnormal clinical laboratory findings, variations in LFTs, abnormal physical examination findings, variations in vital signs and variations in 12-lead ECG
Day 18
Evaluating PK parameters for profiling
Time Frame: Day 4
plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC)
Day 4
Evaluating PK parameters for profiling
Time Frame: Day 4
plasma PK parameters- maximum concentration (Cmax, Clast)
Day 4
Evaluating PK parameters for profiling
Time Frame: Day 4
plasma PK parameters tmax, tlast, kel, t½,
Day 4
Evaluating PK parameters for profiling
Time Frame: Day 4
urine PK paramters (Aeurine)
Day 4
Evaluating PK parameters for profiling
Time Frame: Day 4
feces PK paramters ( Aefeces)
Day 4
Evaluating PK parameters for profiling
Time Frame: Day 4
PMN white blood cell concentrations of WCK 4873.
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wockhardt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2013

Primary Completion (ACTUAL)

June 25, 2013

Study Completion (ACTUAL)

July 13, 2013

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (ACTUAL)

April 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W 4873 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe