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The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.
This study is seeking healthy participants who have:
All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).
The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 | Experimental | Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 3). |
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| Treatment Sequence 2 | Experimental | Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib | Drug | Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg) with 153Sm2O3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Site of capsule disintegration and MR microsphere dispersion | The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation. | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
| Gastric emptying time | Gastric emptying metrics may include a) time of 1st GE; b) time(s) for GE 10%, 25%, 50%, 75%, 90% and complete gastric emptying time GE100%. | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
| Small intestine residence/transit time | Small Intestine transit metrics may include time for 10%, 25%, 50%, 75%, 90% and 100% of the formulation to transit through the small intestine. | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
| Colon arrival time | Arrival time at the colon (ATC) metrics may include a) time(s) for ATC 10%, 25%, 50%, 75%, 90% and 100%. | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
| Colon (ascending, transverse, descending) residence/transit time | The residence time of the formulation in the three primary regions of the large intestine to include the ascending, transverse and descending colon. | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
| Total transit time | Residence time of the formulation in the gastrointestinal tract. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) | Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) |
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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 |
|---|---|---|---|---|---|---|
| Scintipharma - Lexington - Maywick View Lane | Lexington | Kentucky | 40504 | 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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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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| up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) |
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) will be calculated if data permit. |
| Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. |
| Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) | Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. |
| Time for Cmax (Tmax) | Time for Cmax (Tmax) | Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. |
| Terminal half-life (t1/2) | Terminal half-life (t1/2) will be calculated if data permit. | Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. |
| Frequency of adverse events | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. | Baseline up to Day 35 |
| Frequency of abnormal clinical laboratory tests | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. | Baseline up to Day 11 |
| Frequency of abnormal vital signs | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. | Baseline up to Day 11 |
| Frequency of abnormal 12-lead ECG | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. | Baseline up to Day 11 |
| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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