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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03926962

Enrollment

Registered

2019-04-25

Start date

2013-03-14

Completion date

2013-07-13

Last updated

2019-04-25

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 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.

Interventions

DRUGPlacebo Oral Tablet

Visually matching placebo

DRUGWCK 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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	plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC)

Outcome results

None listed

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