The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers

NCT03926962 | Completed Phase 1

• 1 other identifier: W 4873 01
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Assessing incidence of treatment emergent AEs

  Incidence of treatment emergent AEs, abnormal clinical laboratory findings, variations in LFTs, abnormal physical examination findings, variations in vital signs and variations in 12-lead ECG

  Day 18

• Evaluating PK parameters for profiling

  plasma PK parameters -Area under curve (AUC0-t, AUC0-12, AUC0-24, AUC0-inf, %AUC)

  Day 4

• Evaluating PK parameters for profiling

  plasma PK parameters- maximum concentration (Cmax, Clast)

  Day 4

• Evaluating PK parameters for profiling

  plasma PK parameters tmax, tlast, kel, t½,

  Day 4

• Evaluating PK parameters for profiling

  urine PK paramters (Aeurine)

  Day 4

• Evaluating PK parameters for profiling

  feces PK paramters ( Aefeces)

  Day 4

• Evaluating PK parameters for profiling

  PMN white blood cell concentrations of WCK 4873.

  Day 4

Study Arms (2)

WCK 4873

EXPERIMENTAL

100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)

Drug: WCK 4873

Placebo

PLACEBO COMPARATOR

Visually matching placebo

Drug: Placebo Oral Tablet

Interventions

WCK 4873 DRUG

100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)

WCK 4873

Placebo Oral Tablet DRUG

Visually matching placebo

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 : 18-30 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, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
• Medical history without major pathology

You may not qualify if:

• Evidence of clinically relevant pathology
• Mental handicap
• 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 25, 2019
• Study Start: March 14, 2013
• Primary Completion: June 25, 2013
• Study Completion: July 13, 2013
• Last Updated: April 25, 2019

Record last verified: 2019-04