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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505603-23-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to compare if three forms of study medicine (called ritlecitinib) get processed differently in healthy adults.
This study is seeking healthy participants who have:
All participants in this study will receive a ritlecitinib oral dose in three different forms (solution, capsule 1 and capsule 2).
The study will take up to 2.5 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 13 days. There will be 4 periods in total for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first three 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.
Ritlecitinib is a covalent and irreversible inhibitor of JAK3 with high selectivity over the other JAK isoforms (JAK1, JAK2, and TYK2). Ritlecitinib also inhibits irreversibly the TEC family kinases with selectivity over the broader human kinome. Treatment with ritlecitinib is expected to inhibit the inflammatory pathways mediated by IL 7, IL 15 and IL 21, all implicated in UC, CD, AA, RA, and vitiligo and therefore under development in these indications. Moreover, due to lack of activity against the other JAK isoforms, ritlecitinib is expected to spare immunoregulatory cytokines such as IL 10, IL 27 and IL 35, which are critical to the maintenance of immunosuppressive functions and immune homeostasis.
This study aims to investigate the pharmacokinetics (PK) and relative bioavailability of 2 new modified release (MR) capsule formulations of ritlecitinib, MR1 (release duration: 6-8 hours) and MR2 (release duration:13 15 hours) as single doses in fasted and fed conditions.
This is a single dose, open-label, randomized, 4-period, 6-sequence crossover study in a single cohort of approximately 12 healthy participants randomized to one of the sequences (containing 1 solution and 2 modified release [MR1 and MR2] capsule formulations of ritlecitinib) described in the table below. The first 3 periods are under fasted condition and the fourth period is under fed condition to investigate the effect of food on the PK of MR1 and MR2.
For a given participant, the total study duration from screening to follow-up phone call will be between approximately 8 to 11 weeks.
Screening will occur within 28 days prior to the first dose of the study intervention. Each participant will go through Periods 1 through 4 and dosing in each treatment period will be separated by at least 3 days to minimize any carryover effect.
Venous PK blood samples for PK analysis will be collected pre-dose and post-dose in each 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 1 (fasted, Period 2), followed by ritlecitinib 100 mg MR capsule 2 (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 1 (fed, Period 4) |
|
| Treatment Sequence 2 | Experimental | Ritlecitinib 100 mg MR capsule 1 (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule 2 (fasted, Period 2), followed by ritlecitinib 100 mg solution (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 1 (fed, Period 4) |
|
| Treatment Sequence 3 | Experimental | Ritlecitinib 100 mg MR capsule 2 (fasted, Period 1), followed by ritlecitinib 100 mg solution (fasted, Period 2), followed by ritlecitinib 100 mg MR capsule 1 (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 1 (fed, Period 4) |
|
| Treatment Sequence 4 | Experimental | Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule 1 (fasted, Period 2), followed by ritlecitinib 100 mg MR capsule 2 (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 2 (fed, Period 4) |
|
| Treatment Sequence 5 |
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition | For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3 | |
| Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition | AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition | Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed) | |
| AUCinf of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition |
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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 | 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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Participants received treatment in Period 1, 2 or 3 under fasted condition and in Period 4 under fed condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: A Then B Then C Then B (Fed) | Participants were randomized to receive ritlecitinib 100 milligrams (mg) single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as modified release1 (MR1) capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| FG001 | Treatment Sequence 2: B Then C Then A Then B (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| FG002 | Treatment Sequence 3: C Then A Then B Then B (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| FG003 | Treatment Sequence 4: A Then B Then C Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| FG004 | Treatment Sequence 5: B Then C Then A Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| FG005 | Treatment Sequence 6: C Then A Then B Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: A Then B Then C Then B (Fed) | Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition | Pharmacokinetic (PK) parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3 |
|
From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ritlecitinib 100 mg Oral Solution (Fasted) | Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 7, 2023 | Mar 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Mar 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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Ritlecitinib 100 mg MR capsule 1 (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule 2 (fasted, Period 2), followed by ritlecitinib 100 mg solution (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 2 (fed, Period 4) |
|
| Treatment Sequence 6 | Experimental | Ritlecitinib 100 mg MR capsule 2 (fasted, Period 1), followed by ritlecitinib 100 mg solution (fasted, Period 2), followed by ritlecitinib 100 mg MR capsule 1 (fasted, Period 3), and followed by ritlecitinib 100 mg MR capsule 2 (fed, Period 4) |
|
|
AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed) |
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. | From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days) |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory parameters included: Hematology: lymphocytes/leukocytes, eosinophils/leukocytes greater than (>) 1.2*upper limit of normal (ULN) (percent [%]), neutrophils/leukocytes less than (<) 0.8*lower limit of normal (LLN) (%); Urinalysis: urine hemoglobin, nitrite greater than or equal to (>=) 1, bacteria > 20 (per high power field [/HPF]). Clinical significance was judged by investigator. | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position. Criteria for vital signs included: SBP: value less than (<) 90 millimeter of mercury (mmHg), change greater than or equal to (>=) 30 mmHg decrease, change >= 30 mmHg increase; DBP: value < 50 mmHg, change >= 20 mmHg decrease, change >= 20 mmHg increase; PR: value < 40 beats per minute (bpm), value > 120 bpm. Clinical significance was judged by investigator. | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT, corrected QT (Fridericia method) (QTcF) and QRS intervals. Clinical significance was judged by investigator. | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Treatment Sequence 2: B Then C Then A Then B (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| BG002 | Treatment Sequence 3: C Then A Then B Then B (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| BG003 | Treatment Sequence 4: A Then B Then C Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| BG004 | Treatment Sequence 5: B Then C Then A Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| BG005 | Treatment Sequence 6: C Then A Then B Then C (Fed) | Participants were randomized to receive ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution [A] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2*50 mg) single oral dose as MR1 capsules [B] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2*50 mg) single oral dose as MR2 capsules [C] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours. |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3. |
| OG002 | Ritlecitinib 100 mg MR2 Capsule (Fasted) | Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3. |
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| Primary | Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition | AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*Hour per milliliter (ng*hr/mL) | For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3 |
|
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|
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| Secondary | Cmax of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition | PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed) |
|
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|
|
| Secondary | AUCinf of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition | AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*Hour per milliliter (ng*hr/ mL) | Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed) |
|
|
|
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory parameters included: Hematology: lymphocytes/leukocytes, eosinophils/leukocytes greater than (>) 1.2*upper limit of normal (ULN) (percent [%]), neutrophils/leukocytes less than (<) 0.8*lower limit of normal (LLN) (%); Urinalysis: urine hemoglobin, nitrite greater than or equal to (>=) 1, bacteria > 20 (per high power field [/HPF]). Clinical significance was judged by investigator. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
|
|
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| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position. Criteria for vital signs included: SBP: value less than (<) 90 millimeter of mercury (mmHg), change greater than or equal to (>=) 30 mmHg decrease, change >= 30 mmHg increase; DBP: value < 50 mmHg, change >= 20 mmHg decrease, change >= 20 mmHg increase; PR: value < 40 beats per minute (bpm), value > 120 bpm. Clinical significance was judged by investigator. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT, corrected QT (Fridericia method) (QTcF) and QRS intervals. Clinical significance was judged by investigator. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Ritlecitinib 100 mg MR1 Capsules (Fasted) | Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3. | 0 | 11 | 0 | 11 | 5 | 11 |
| EG002 | Ritlecitinib 100 mg MR2 Capsules (Fasted) | Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG003 | Ritlecitinib 100 mg MR1 Capsules (Fed) | Participants received Ritlecitinib 100 mg as oral MR1 capsules under fed conditions on Day 1 of Period 4. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | Ritlecitinib 100 mg MR2 Capsules (Fed) | Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4. | 0 | 6 | 0 | 6 | 1 | 6 |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect. |
| Ratio of Adjusted Geometric Means |
| 76.99 |
| 2-Sided |
| 90 |
| 70.65 |
| 83.90 |
Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution. |
| Other |
A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect. |
| Ratio of Adjusted Geometric Means |
| 129.79 |
| 2-Sided |
| 90 |
| 111.51 |
| 151.06 |
Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted). |
| Other |
A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect. |
| Ratio of Adjusted Geometric Means |
| 109.63 |
| 2-Sided |
| 90 |
| 99.19 |
| 121.17 |
Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted). |
| Other |