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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

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ClinicalTrials.gov Identifier: NCT03926962
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Wockhardt

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 Intervention/treatment Phase
Healthy Drug: WCK 4873 Drug: Placebo Oral Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
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 14, 2013
Actual Primary Completion Date : June 25, 2013
Actual Study Completion Date : July 13, 2013

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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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)
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Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT03926962    
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
Additional relevant MeSH terms:
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Nafithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action