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Completed

NCT Number: NCT03979859

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

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).

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WCK 4873

Drug

Placebo oral tablet

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2019
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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