Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

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

This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• 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 : 18.0-30.0 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, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
• Medical history without major pathology as judged by the Principal Investigator
• Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
• Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be <450 ms

Exclusion Criteria:

• Previous participation in the current study
• Evidence of clinically relevant pathology
• Mental handicap
• History of Myasthenia Gravis
• History of hepatitis and/or jaundice associated with the use of any antibiotic
• Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
• 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 Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WCK 4873; 200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study	Drug: WCK 4873
Placebo Comparator: Placebo; Visually matching placebo	Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing incidence of treatment emergent AEs	By abnormal clinical laboratory (including liver function tests) findings	Day 24
Assessing incidence of treatment emergent AEs	By variation in physical examination	Day 24
Assessing incidence of treatment emergent AEs	By abnormal findings in eye movement test and visual acuity test	Day 24
Assessing incidence of treatment emergent AEs	By abnormal vital signs	Day 24
Assessing incidence of treatment emergent AEs	variations in 12-lead electrocardiogram	Day 24
Measure the pharmacokinetic parameter: Area Under Curve (AUC)	plasma PK parameters area under curve (AUC)	Day 10
Measure the pharmacokinetic parameter-plasma PK concentration	Plasma concentration -Cmax	Day 10
Measure the pharmacokinetic parameter- Time	Plasma PK parameter- Tmax	Day 10
Measure the pharmacokinetic parameter- Time	Plasma PK parameter- T1/2	Day 10

Collaborators and Investigators

• Sponsor: Wockhardt

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2013
• Primary Completion (Actual): December 5, 2013
• Study Completion (Actual): December 30, 2013

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 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 02