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

NCT03979859 | Completed Phase 1

• 1 other identifier: W 4873 02
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

WCK 4873

EXPERIMENTAL

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

PLACEBO COMPARATOR

Visually matching placebo

Drug: Placebo Oral Tablet

Interventions

WCK 4873 DRUG

WCK 4873

Placebo Oral Tablet DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wockhardt: lead

MeSH Terms

Interventions

nafithromycin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: June 7, 2019
• Study Start: August 20, 2013
• Primary Completion: December 5, 2013
• Study Completion: December 30, 2013
• Last Updated: June 11, 2019

Record last verified: 2019-06