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Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg PG 760564, Subjects Fasted | Experimental | 200 mg PG 760564, Subjects Fasted, single dose |
|
| 200 mg PG 760564, Subjects Fed | Experimental | 200 mg PG 760564, Subjects Fed high fat meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-760564 | Drug | 200 mg capsule, single dose,fasted when dosed, duration is 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration after a single dose | over 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William S Aronstein, MD, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stuart I Harris, MD, PhD | Miami | Florida | 33126 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg PG 760564. Fed Then Fasted | 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state |
| FG001 | 200 mg PG 760564. Fasted | 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1: Single Dose Followed by Week Washout |
| |||||||||||||
| 2: Single Dose |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg PG 760564. Fed Then Fasted | 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state |
| BG001 | 200 mg PG 760564. Fasted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | Maximum plasma concentration after a single dose | Posted | Geometric Mean | Standard Deviation | ng/mL | over 12 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 mg PG 760564. Fed Then Fasted | 200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heme-positive stool | Gastrointestinal disorders | MeDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Thomas | Procter & Gamble | 513.622.4838 | thomas.pr@pg.com |
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| PG-760564 | Drug | 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days |
|
| NOT COMPLETED |
|
200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Study is a crossover study. All subjects received Investigational Product in BOTH the Fed and Fasted state | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | 200 mg PG 760564. Fasted | 200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state | 0 | 10 | 0 | 10 |
Data, calculations, interpretations, opinions, and recommendations are the property of P&GP. In the event study results are published in the scientific literature by P&GP, acknowledgment will be made to the Investigator(s) in the accepted style, as appropriate.