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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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