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

Phase 1

Completed

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

• Registration Number: NCT03979859
• Lead Sponsor: Wockhardt

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-20
• Primary Completion: 2013-12-05
• Study Completion: 2013-12-30
• Study First Submitted: 2019-04-03
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WCK 4873	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
Placebo	Placebo Oral Tablet	Visually matching placebo

Primary Outcome Measures

Name	Time	Method
Measure the pharmacokinetic parameter- Time	Day 10	Plasma PK parameter- T1/2
Measure the pharmacokinetic parameter-plasma PK concentration	Day 10	Plasma concentration -Cmax
Measure the pharmacokinetic parameter: Area Under Curve (AUC)	Day 10	plasma PK parameters area under curve (AUC)
Assessing incidence of treatment emergent AEs	Day 24	variations in 12-lead electrocardiogram