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Completed

NCT Number: NCT03926962

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WCK 4873

Drug

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 oral tablet

Drug

Visually matching placebo

Primary outcomes

  1. Assessing incidence of treatment emergent AEs

    Time frame: 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

  2. Evaluating PK parameters for profiling

    Time frame: Day 4

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

  3. Evaluating PK parameters for profiling

    Time frame: Day 4

    plasma PK parameters- maximum concentration (Cmax, Clast)

  4. Evaluating PK parameters for profiling

    Time frame: Day 4

    plasma PK parameters tmax, tlast, kel, t½,

  5. Evaluating PK parameters for profiling

    Time frame: Day 4

    urine PK paramters (Aeurine)

  6. Evaluating PK parameters for profiling

    Time frame: Day 4

    feces PK paramters ( Aefeces)

  7. Evaluating PK parameters for profiling

    Time frame: Day 4

    PMN white blood cell concentrations of WCK 4873.

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2019
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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