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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fed state in PART B | Experimental |
| |
| fasted state in PART B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG-549 | Drug | PART A (open-label) Period 1: single oral dose. Period 2: After PK evaluation of period 1. Period 3: After PK evaluation of period 2. PART B (randomized)
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of CG549 | up to 4 weeks | |
| Area Under the Concentration-Time Curve (AUC) of CG549 | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Experienced Serious or Non-Serious Adverse Events | up to 4 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Velinova, Ph.D | PRA Health Sciences (PRA) - Early Development Services (EDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences (PRA) - Early Development Services (EDS) | Groningen | Netherlands |
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Randomized cross-over study
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