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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001649-28 | EudraCT Number |
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This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort.
For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1_90mg and Matching Placebo | Experimental |
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| Cohort 2_300mg and Matching Placebo | Experimental |
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| Cohort 3_900mg and Matching Placebo | Experimental |
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| Cohort 4_1800mg and Matching Placebo | Experimental |
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| Cohort 5_3000mg and Matching Placebo | Experimental |
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| Optional Cohort 6_TBD mg and Matching Placebo | Experimental |
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| Optional Cohort 7_TBD mg and Matching Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) | Number of participants with reported adverse events | Baseline 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 24 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 24 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 24 days after last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06865571 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14 | |
| AUCtau for PF-06865571 | Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state. |
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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 | ||
| Pfizer Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36690550 | Derived | Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21. |
| 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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| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| PF-06865571 | Drug | Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD. |
|
| Placebo | Drug | Matching Placebo for PF-06865571 for each cohort. |
|
| 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14 |
| 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 hour post dose on Days 1, 7, and 14 |
| 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 hour post dose on Days 1, 7, and 14 |
| Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571 | Sum of [urine concentration * sample volume] for each collection over the dosing interval | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 |
| Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571 | 100* Aetau/Dose | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 |
| Renal clearance (CLr) for PF-06865571 | Aetau/AUCtau | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14 |
| Brussels |
| B-1070 |
| Belgium |
| To obtain contact information for a study center near you, click here. | View source |
| ID | Term |
|---|---|
| C000726790 | ervogastat |
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