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

  • Clinicaltrials.gov identifier

    NCT03926962

  • Recruitment Status

    Completed

  • First Posted

    April 25, 2019

  • Last update posted

    April 25, 2019

Study Description

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.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Drug: WCK 4873
    Drug: Placebo Oral Tablet
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 67 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official 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
  • Actual Study Start Date: March 2013
  • Actual Primary Completion Date: June 2013
  • Actual Study Completion Date: July 2013

Arms and interventions

Arm Intervention/treatment
Experimental: WCK 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)
Drug: WCK 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)
Placebo Comparator: Placebo
Visually matching placebo
Drug: Placebo Oral Tablet
Visually matching placebo

Outcome Measures

  • Primary Outcome Measures: 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Wockhardt

More Information

  • Responsible Party: Wockhardt
  • ClinicalTrials.gov Identifier: NCT03926962 History of Changes
  • Other Study ID Numbers: W 4873 01
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019