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Clinical Trial Summary

this study will be a Phase 1, single-dose, two parallel cohorts, open-label, randomized study in healthy subjects with Cohort 1 as bioequivalence (BE) and food effect study and Cohort 2 as a drug-drug interaction (DDI) study.


Clinical Trial Description

Cohort 1 (BE) is a four-period, four-sequence, four-treatment crossover BE and food effect study of zoliflodacin granules for oral suspension manufactured by Dr. Reddy's (test product, ZoliDr) and those manufactured by Patheon (reference product, ZoliPa) as a 3 g oral dose under fasting and a [specific] fed condition. This cohort will comprise of approximately 32 subjects (8 healthy subjects per treatment sequence) in 4 x 4 BE treatment arms in fasted and [specific] fed conditions. Healthy subjects will be randomized into 4 parallel treatment sequences to receive sequential Treatments A, B, C, and D in William's Square design pattern where: - Treatment A is ZoliPa fasted - Treatment B is ZoliDr fasted - Treatment C is ZoliPa [specific] fed condition - Treatment D is ZoliDr [specific] fed condition Based on William's Square design, below treatment sequences will be followed: A-B-C-D B-A-D-C C-D-A-B D-C-B-A There will be 4 treatment periods, each with a single dose of the investigational medicinal products (IMP). The washout period between each IMP administration will be at least 72 hours. Food regimen: Subjects, who are in a treatment period in which they are [specific] fed, will be dosed 30 minutes after the start of food intake. The subjects are expected to consume the entire meal within 30 minutes prior to dosing. Cohort 2 (DDI): This is an open-label, 2-period, 2-treatment, fixed sequence crossover DDI study in healthy subjects. It will investigate PK of zoliflodacin (ZoliPa) in the absence and presence of itraconazole. Approximately 18 subjects will receive ZoliPa on Day 1 under fasting condition. After a washout of 72 hours after dosing of ZoliPa, on Day 4, subjects will receive a 400 mg loading dose of itraconazole followed by 200 mg of itraconazole once daily from Day 5-8. From Day 4 to Day 8, itraconazole will be administered immediately after a full meal. On Day 9, both itraconazole and zoliflodacin (ZoliPa) will be administered under fasting conditions at -1 hours and 0 hours, respectively. Itraconazole will then be administered with food at 24 hours (Day 10) and 48 hours (Day 11) after administration of zoliflodacin (ZoliPa). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05635305
Study type Interventional
Source Global Antibiotics Research and Development Partnership
Contact
Status Completed
Phase Phase 1
Start date November 9, 2022
Completion date February 7, 2023

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