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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003012-30 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of PF-07081532 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants receiving PF-07081532 |
|
| Placebo | Placebo Comparator | Participants receiving Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07081532 | Drug | Participants will receive single ascending doses PF-07081532 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events | From screening until follow-up call (28-35 days after the last dose of investigational product) | |
| Percentage of participants with safety laboratory test results above/below certain threshold | Days -1, 2 and 4 of each period and at follow-up visit (7-14 days after the last dose of investigational product) | |
| Percentage of participants with vital signs above/below certain threshold | Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product) | |
| Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold | Days 1-4 of each period and at follow-up visit (7-14 days after the last dose of investigational product) |
| Measure | Description | Time Frame |
|---|---|---|
| PF-07081532 AUClast | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration | Days 1-4 of each period |
| PF-07081532 AUCinf | Area under the plasma concentration-time profile from time 0 extrapolated to infinite time |
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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 |
|---|---|---|---|---|---|---|
| Brussels Clinical Research Unit | Brussels | Bruxelles-capitale, Région de | 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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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This study is a double-blinded (investigator- and participant-blinded), sponsor-open, randomized, single-ascending oral dose, 4-period crossover, placebo substitution design in 2 interleaving cohorts of healthy adult participants. An additional cohort, enrolling healthy adult participants in up to 4 crossover periods, may be included to permit assessment of any of the following: repeat of a previously administered dose level; studying additional dose levels as dictated by the evaluated safety, tolerability or PK of earlier dose levels; or any other assessment needed to meet the objectives of this study. A cohort enrolling Japanese participants to receive PF-07081532 or placebo in up to 3 periods, may be included.
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| Placebo |
| Drug |
Participants will receive placebo |
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| Days 1-4 of each period |
| PF-07081532 Cmax | Maximum plasma concentration | Days 1-4 of each period |
| PF-07081532 Tmax | Time for maximum plasma concentration | Days 1-4 of each period |
| PF-07081532 t1/2 | Terminal half-life | Days 1-4 of each period |