Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690932
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2023-01-10
Brief Title:
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
Sponsor:
Pyramid Biosciences
Organization:
Pyramid Biosciences
Study Overview
Official Title:
A Single-Dose Open-Label Two-Part Randomized Crossover Formulation Bridging and Food Effect Study to Assess the Effect of Formulation and Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-01
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 is a single-dose two-part crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal healthy volunteers
Detailed Description:
This is a single-dose two-part crossover formulation bridging Part A and tablet food effect Part B study in normal healthy volunteers Part A will be conducted to evaluate the pharmacokinetics PK and relative bioavailability of 3 formulations of PBI-200 each volunteer will serve as their own control In Part B PBI-200 tablets will be dosed under fasting and fed low-fat and high-fat meals conditions to evaluate the effect of food on the PK of PBI-200
Study Oversight
Has Oversight DMC:
None
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?:
None