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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001298-17 | EudraCT Number |
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This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06651600 | Experimental | Multiple ascending doses of PF-06651600 |
|
| Placebo | Placebo Comparator | Multiple ascending doses of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 | Drug | PF-06651600 will be administered as tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Baseline up to Day 45 | |
| Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate) | Baseline, 1 hour post-dose on Day 1 and 10 | |
| Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature) | Baseline, Day 1, 10, 12 and 28 | |
| Number of Participants With Change From Baseline in Physical Examinations | Baseline up to Day 28 | |
| Number of Participants With Laboratory Abnormalities | Baseline up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 | |
| Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917289 | Derived | Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2. |
| 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 |
|---|---|
| C000614924 | PF-06651600 |
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| Placebo |
| Drug |
Matching placebo will be administered as tablet |
|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
| Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1 |
| Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
| Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
| Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |
| MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10 | pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10 |