drugset / Trial / NCT03979859

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

NCT03979859

Phase 1 Completed 30 enrolled Wockhardt
RandomizedParallel-groupTriple-blindOther

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).

Timeline

Start
2013-08-20
Primary completion
2013-12-05
Completion
2013-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nafithromycin Small molecule 200 mg Oral
Subject Nafithromycin Small molecule 400 mg Oral

Indications

No indication recorded.