Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT05393856
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2019-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CG-549 Tablet Pharmacokinetics Study
Sponsor:
CrystalGenomics, Inc.
Organization:
Study Overview
Official Title:
CG-549 Tablet Pharmacokinetics Study: An Open-label, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of a Tablet Formulation of CG-549 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-05
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 will be an open label, crossover, single dose study consisting of 2 parts (Part A and Part B) in a total of 24 healthy male and female subjects.
Detailed Description:
Part A Part A is an open-label, 3-period, fixed-sequence, escalating dose study in 6 healthy subjects to find a tablet dose that results in a CG-549 exposure that is expected to be safe and potentially efficacious (i.e., within the targeted efficacious exposure range as defined below).
Subjects will receive the following treatments of the tablet formulation of CG-549, in the fed state:
* Period 1: a single oral dose of 300 mg CG-549 on Day 1.
* Period 2: a single oral dose of XX mg CG-549 on Day 1. After interim PK evaluation of Period 1, the CG-549 dose of Period 2 will aim at reaching the lower end of the targeted efficacious exposure range.
* Period 3: a single oral dose of YY mg CG-549 on Day 1. After interim PK evaluation of Period 2, the CG-549 tablet dose of Period 3 will aim at reaching the higher end of the targeted efficacious exposure range.
Doses XX and YY will be multiples of 300 mg and will not exceed 3 times the dose used in the preceding period.
After interim PK evaluation of all periods in Part A, the CG-549 dose and the type of breakfast to be used in Part B will be selected which is anticipated to result in an exposure that is expected to be safe and potentially efficacious.
Part B Part B is an open-label, 2-period, randomized crossover study in 18 healthy subjects to confirm that the selected dose of the tablet formulation of CG-549 results in a CG-549 exposure that is expected to be safe and potentially efficacious, and to compare the PK profiles of a single dose of the tablet formulation of CG 549 between the fed and the fasted states.
Subjects will receive the following treatments of the tablet formulation of CG-549:
* Period 1: a single oral dose of ZZ mg CG-549 on Day 1 in fed or fasted state.
* Period 2: a single oral dose of ZZ mg CG-549 on Day 1 in fasted or fed state. Dose ZZ will be a multiple of 300 mg.
There will be 2 treatment sequences in the study: fed-fasted and fasted-fed. Subjects will be randomly assigned to a treatment sequence in a 1:1 ratio. In the fed state, subjects will either receive a high-fat or a medium fat breakfast.
Subjects will receive the following treatments of the tablet formulation of CG-549, in the fed state:
* Period 1: a single oral dose of 300 mg CG-549 on Day 1.
* Period 2: a single oral dose of XX mg CG-549 on Day 1. After interim PK evaluation of Period 1, the CG-549 dose of Period 2 will aim at reaching the lower end of the targeted efficacious exposure range.
* Period 3: a single oral dose of YY mg CG-549 on Day 1. After interim PK evaluation of Period 2, the CG-549 tablet dose of Period 3 will aim at reaching the higher end of the targeted efficacious exposure range.
Doses XX and YY will be multiples of 300 mg and will not exceed 3 times the dose used in the preceding period.
After interim PK evaluation of all periods in Part A, the CG-549 dose and the type of breakfast to be used in Part B will be selected which is anticipated to result in an exposure that is expected to be safe and potentially efficacious.
Part B Part B is an open-label, 2-period, randomized crossover study in 18 healthy subjects to confirm that the selected dose of the tablet formulation of CG-549 results in a CG-549 exposure that is expected to be safe and potentially efficacious, and to compare the PK profiles of a single dose of the tablet formulation of CG 549 between the fed and the fasted states.
Subjects will receive the following treatments of the tablet formulation of CG-549:
* Period 1: a single oral dose of ZZ mg CG-549 on Day 1 in fed or fasted state.
* Period 2: a single oral dose of ZZ mg CG-549 on Day 1 in fasted or fed state. Dose ZZ will be a multiple of 300 mg.
There will be 2 treatment sequences in the study: fed-fasted and fasted-fed. Subjects will be randomly assigned to a treatment sequence in a 1:1 ratio. In the fed state, subjects will either receive a high-fat or a medium fat breakfast.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: