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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03979859

Enrollment

Registered

2019-06-07

Start date

2013-08-20

Completion date

2013-12-30

Last updated

2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

Interventions

DRUGWCK 4873

DRUGPlacebo Oral Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Assessing incidence of treatment emergent AEs	Day 24	By abnormal clinical laboratory (including liver function tests) findings
Measure the pharmacokinetic parameter: Area Under Curve (AUC)	Day 10	plasma PK parameters area under curve (AUC)
Measure the pharmacokinetic parameter-plasma PK concentration	Day 10	Plasma concentration -Cmax
Measure the pharmacokinetic parameter- Time	Day 10	Plasma PK parameter- Tmax

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026