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The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06700841: IR, MR1, MR2, MR1_fed | Experimental | Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4 |
|
| PF-06700841: MR1, MR2, IR, MR1_fed | Experimental | Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4 |
|
| PF-06700841: MR2, IR, MR1, MR1_fed | Experimental | Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4 |
|
| PF-06700841: IR, MR1, MR2, MR2_fed | Experimental | Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4 |
|
| PF-06700841: MR1, MR2, IR, MR2_fed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 IR | Drug | Immediate release formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A | pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose | |
| Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A | pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose | |
| Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A | pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose | |
| Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A | pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose | |
| Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B | Baseline to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A | Pre-dose and 96 hours post dose | |
| Number of subjects with clinically relevant changes in vital signs in Part A | Pre-dose and 96 hours post dose |
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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 |
|---|---|---|---|---|---|---|
| Quotient Sciences | Coral Gables | Florida | 33134 | United States | ||
| Quotient Sciences-Miami |
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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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Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition.
Part B is a multiple ascending dose study
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Part B is a sponsor open, double blind study where the investigator, medical monitor and the participants will be blinded.
Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4 |
|
| PF-06700841: MR2, IR, MR1, MR2_fed | Experimental | Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4 |
|
| PF-06700841 MR3 (Dose A) or matching placebo | Experimental | Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition |
|
| PF-06700841 MR3 (Dose B) or matching placebo | Experimental | Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition |
|
| PF-06700841 MR3 (Dose C) or matching placebo | Experimental | Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition |
|
| PF-06700841 MR1 | Drug | Modified release formulation 1 |
|
| PF-06700841 MR2 | Drug | Modified release formulation 2 |
|
| PF-06700841 MR3 | Drug | Modified release formulation 3 |
|
| Placebo | Other | Matching placebo |
|
| Number of participants with clinically relevant changes in clinical laboratory tests in Part A | Baseline and 96 hours post dose |
| Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A | Baseline to Day 4 |
| Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1 | pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1 |
| Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1 | pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1 |
| Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7 | pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7 |
| Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7 | pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7 |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1 | pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7 | pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 |
| Terminal half-life of PF-06700841 in Part B | pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7 |
| Miami |
| Florida |
| 33126 |
| United States |