Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05635305
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2022-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
Sponsor:
Global Antibiotics Research and Development Partnership
Organization:
Study Overview
Official Title:
A Phase 1, Single-dose, Open-label, Randomized, 4-way Crossover Zoliflodacin Bioequivalence Study of the Reference Product (ZoliPa) With the Test Product (ZoliDr) in Healthy Adult Volunteers Under Fasted and Specific Fed Conditions Paired With an Investigation of the Effect of Cytochrome P450 3A4 Inhibition by Itraconazole on 3g Zoliflodacin (ZoliPa) Single-dose Pharmacokinetics
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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).
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: