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

Wockhardt67 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

WCK 4873DRUG

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 Oral TabletDRUG

Visually matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: Day 18