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

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: Healthy
• Intervention / Treatment: Drug: WCK 4873; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC)	Day 4
Evaluating PK parameters for profiling	plasma PK parameters- maximum concentration (Cmax, Clast)	Day 4
Evaluating PK parameters for profiling	plasma PK parameters tmax, tlast, kel, t½,	Day 4
Evaluating PK parameters for profiling	urine PK paramters (Aeurine)	Day 4
Evaluating PK parameters for profiling	feces PK paramters ( Aefeces)	Day 4
Evaluating PK parameters for profiling	PMN white blood cell concentrations of WCK 4873.	Day 4

Collaborators and Investigators

• Sponsor: Wockhardt

Study record dates

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: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Nafithromycin
• Other Study ID Numbers: W 4873 01