Clinical trial NCT03979859: Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2019-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility 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)

Primary outcomes:
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 24
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 24
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 24
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 24
measure: Assessing incidence of treatment emergent AEs
timeFrame: Day 24
measure: Measure the pharmacokinetic parameter: Area Under Curve (AUC)
timeFrame: Day 10
measure: Measure the pharmacokinetic parameter-plasma PK concentration
timeFrame: Day 10
measure: Measure the pharmacokinetic parameter- Time
timeFrame: Day 10
measure: Measure the pharmacokinetic parameter- Time
timeFrame: Day 10
Secondary outcomes:
Other outcomes:
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