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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003649-24 | EudraCT Number |
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The purpose of this study is to evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.
The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | All subjects will receive 2 treatments in one of the indicated sequence orders: A - B B - A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04136309 | Drug | Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets. Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from time Zero to Extrapolated Infinite Time (AUC[0-inf]). | AUC(0-inf)=Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (o-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours (hrs) post-PF-04136309 dose |
| Maximum Plasma Concentration [Cmax] | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast). | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 |
| Time to Reach maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000620181 | PF-04136309 |
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Time for Cmax |
| 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose |
| Plasma Decay Half Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 |
| Apparent Oral Clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post-PF-04136309 dose |
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose |