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The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1_Active and Matching Placebo | Experimental |
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| Cohort 2_Active and Matching Placebo | Experimental |
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| Cohort 3_Active and Matching Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06865571 | Drug | Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 5 mg, 50 mg, 500 mg, TBD (to be determined)/2000 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) | Number of participants with reported adverse events | Screening up to 35 days after last dose of study medication |
| Number of subjects with laboratory tests findings of potential clinical importance | Number of participants with potentially clinically important laboratory test findings | Baseline (Day 0) up to 14 days after last dose of study medication |
| Number of subjects with vital signs findings of potential clinical importance | Number of participants with potentially clinically important vital sign measurements | Baseline (Day 0) up to 14 days after last dose of study medication |
| Number of subjects with electrocardiogram (ECG) findings of potential clinical importance | Number of participants with potentially clinically important ECG findings | Baseline (Day 0) up to 14 days after last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571 |
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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 New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| C000726790 | ervogastat |
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| PF-06865571 | Drug | Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 15 mg, 150 mg, 1000 mg, TBD/2000 mg. |
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| PF-06865571 | Drug | Single repeated (TBD mg) dose as extemporaneously prepared solution/suspension of PF-06865571. |
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| Placebo | Drug | Matching Placebo for PF-06865571 for each cohort. |
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AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity). |
| 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Dose normalized AUClast for PF-06865571 | dose normalized AUC will be analysed using a mixed model appropriate to the study design | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Dose normalized AUCinf for PF-06865571 | Following log-transformation, dose normalized AUCinf will be analysed using a mixed model appropriate to the study design. | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Maximum Observed Plasma Concentration (Cmax) for PF-06865571 | Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Dose normalized Cmax for PF-06865571 | Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design. | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Time to Reach Maximum Observed Concentration for PF-06865571 | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Plasma Decay Half-Life (t1/2) for PF-06865571 | Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Apparent Oral Clearance (CL/F) for PF-06865571 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |
| Apparent Volume of Distribution (Vz/F) for PF-06865571 | 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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours post dose in each period |