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出境医 / 临床实验 / Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

Study Description
Brief Summary:
This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Actual Study Start Date : August 20, 2013
Actual Primary Completion Date : December 5, 2013
Actual Study Completion Date : December 30, 2013
Arms and Interventions
Arm Intervention/treatment
Experimental: WCK 4873
200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study
Drug: WCK 4873
Placebo Comparator: Placebo
Visually matching placebo
Drug: Placebo Oral Tablet
Outcome Measures
Primary Outcome Measures :
  1. Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal clinical laboratory (including liver function tests) findings

  2. Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By variation in physical examination

  3. Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal findings in eye movement test and visual acuity test

  4. Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal vital signs

  5. Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    variations in 12-lead electrocardiogram

  6. Measure the pharmacokinetic parameter: Area Under Curve (AUC) [ Time Frame: Day 10 ]
    plasma PK parameters area under curve (AUC)

  7. Measure the pharmacokinetic parameter-plasma PK concentration [ Time Frame: Day 10 ]
    Plasma concentration -Cmax

  8. Measure the pharmacokinetic parameter- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- Tmax

  9. Measure the pharmacokinetic parameter- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- T1/2


Eligibility Criteria
Layout table for eligibility information
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 : 18.0-30.0 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, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
  • Medical history without major pathology as judged by the Principal Investigator
  • Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
  • Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be <450 ms

Exclusion Criteria:

  • Previous participation in the current study
  • Evidence of clinically relevant pathology
  • Mental handicap
  • History of Myasthenia Gravis
  • History of hepatitis and/or jaundice associated with the use of any antibiotic
  • Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
  • 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

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE August 20, 2013
Actual Primary Completion Date December 5, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal clinical laboratory (including liver function tests) findings
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By variation in physical examination
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal findings in eye movement test and visual acuity test
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal vital signs
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    variations in 12-lead electrocardiogram
  • Measure the pharmacokinetic parameter: Area Under Curve (AUC) [ Time Frame: Day 10 ]
    plasma PK parameters area under curve (AUC)
  • Measure the pharmacokinetic parameter-plasma PK concentration [ Time Frame: Day 10 ]
    Plasma concentration -Cmax
  • Measure the pharmacokinetic parameter- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- Tmax
  • Measure the pharmacokinetic parameter- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- T1/2
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal clinical laboratory (including liver function tests) findings
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By variation in physical examination
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal findings in eye movement test and visual acuity test
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    By abnormal vital signs
  • Assessing incidence of treatment emergent AEs [ Time Frame: Day 24 ]
    variations in 12-lead electrocardiogram
  • Measure the Pharmcokinetics Parameter: Area Under Curve (AUC) [ Time Frame: Day 10 ]
    plasma PK parameters area under curve (AUC)
  • Measure the Pharmcokinetics Parameters-plasma PK concentration [ Time Frame: Day 10 ]
    Plasma concentration -Cmax
  • Measure the Pharmcokinetics Parameters- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- Tmax
  • Measure the Pharmcokinetics Parameters- Time [ Time Frame: Day 10 ]
    Plasma PK parameter- T1/2
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Official Title  ICMJE Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Brief Summary This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: WCK 4873
  • Drug: Placebo Oral Tablet
Study Arms  ICMJE
  • Experimental: WCK 4873
    200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study
    Intervention: Drug: WCK 4873
  • Placebo Comparator: Placebo
    Visually matching placebo
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2019)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2013
Actual Primary Completion Date December 5, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI : 18.0-30.0 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, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
  • Medical history without major pathology as judged by the Principal Investigator
  • Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
  • Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be <450 ms

Exclusion Criteria:

  • Previous participation in the current study
  • Evidence of clinically relevant pathology
  • Mental handicap
  • History of Myasthenia Gravis
  • History of hepatitis and/or jaundice associated with the use of any antibiotic
  • Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979859
Other Study ID Numbers  ICMJE W 4873 02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wockhardt
Study Sponsor  ICMJE Wockhardt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wockhardt
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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