Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-02 @ 8:40 PM
Study NCT ID:
NCT06486558
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study of HU6
Sponsor:
Rivus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Randomized, Two-Part Study to Assess the Safety and Pharmacokinetics of Tablet and Capsule Formulations of HU6 in Healthy Subjects.
Status:
COMPLETED
Status Verified Date:
2025-04
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 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.
Detailed Description:
This is a 2-part study. Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Forty subjects will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) or capsule (reference) formulation in the fasted state. Fourteen days will separate dosing in Period 1 and Period 2. After Part 1 is completed, the Part 1 pharmacokinetic blood samples will be shipped for bioanalysis. Study conduct will proceed to Part 2. Fourteen days will separate dosing in Part 1 Period 2 and Part 2 Period 1.
Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2
Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2
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?: