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
Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
August 20, 2013
Actual (reported)Primary Completion
December 5, 2013
Actual (reported)Study Completion
December 30, 2013
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 20, 2013
Actual (reported)December 5, 2013
Actual (reported)December 30, 2013
Actual (reported)April 3, 2019
Actual (reported)June 7, 2019
Actual (reported)Assessing incidence of treatment emergent AEs
By abnormal clinical laboratory (including liver function tests) findings
Day 24
Assessing incidence of treatment emergent AEs
By variation in physical examination
Day 24
Assessing incidence of treatment emergent AEs
By abnormal findings in eye movement test and visual acuity test
Day 24
Assessing incidence of treatment emergent AEs
By abnormal vital signs
Day 24
Assessing incidence of treatment emergent AEs
variations in 12-lead electrocardiogram
Day 24
Measure the pharmacokinetic parameter: Area Under Curve (AUC)
plasma PK parameters area under curve (AUC)
Day 10
Measure the pharmacokinetic parameter-plasma PK concentration
Plasma concentration -Cmax
Day 10
Measure the pharmacokinetic parameter- Time
Plasma PK parameter- Tmax
Day 10
Measure the pharmacokinetic parameter- Time
Plasma PK parameter- T1/2
Day 10
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
Visually matching placebo
30 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2019
First Posted
June 7, 2019
Study Start
August 20, 2013
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 5, 2013
Actual (reported)Study Completion
December 30, 2013
Actual (reported)Last Updated
June 11, 2019
Record last verified: 2019-06
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Source: ClinicalTrials.gov.
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