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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: WCK 4873; Drug: Placebo Oral Tablet

• Registration Number: NCT03926962
• Lead Sponsor: Wockhardt

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-03-14
• Primary Completion: 2013-06-25
• Study Completion: 2013-07-13
• Status Verified: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-24
• Last Update Submitted: 2019-04-24
• Study First Posted: 2019-04-25
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WCK 4873	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	Placebo Oral Tablet	Visually matching placebo

Primary Outcome Measures

Name	Time	Method
Assessing incidence of treatment emergent AEs	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
Evaluating PK parameters for profiling	Day 4	PMN white blood cell concentrations of WCK 4873.