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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502872-22-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.
This study is seeking participants who are:
The study will take up to 2.5 months, including the screening period. There will be 5 periods in total for this study. Participants will have to stay at the study clinic for at least 11 days. Participants will take Riltecitinib either as sprinkled in Soft Food or as Intact Blend-In Capsule. On day 1 of each period, participants will take Riltecitinib and have blood samples taken both before and afterwards. Participants will also answer questions for taste assessment purpose. 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 tyrosine kinase expressed in 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. 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.
The objective of this study is to estimate the impact of administration methods on the bioavailability of the pediatric ritlecitinib intact BiC formulation. The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-crossover periods and 1-fixed period design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment. Blood samples will be collected for PK analysis. A taste assessment will be also conducted.
Participants will participate in the study for up to approximately 2.5 months, with the inclusion of the screening and follow-up period. On Day 1 of each period, participants will receive a single dose of IP. Administration of IP will be via dosing using intact BiCs with water or by emptying the capsule contents on soft food as per dosing instructions.
Participants will be confined in the CRU for a total of at least 11 days and discharged at the discretion of the investigator. A follow-up phone call will be made at least 28 calendar days and up to 35 calendar days after the last administration of the study intervention to capture any potential AE and confirm appropriate contraceptive usage.
Tolerability and safety will be assessed for all treatments by monitoring AEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | ritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state |
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| Treatment B | Active Comparator | contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state |
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| Treatment C | Active Comparator | contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state |
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| Treatment D | Active Comparator | contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state |
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| Treatment E | Active Comparator | ritlecitinib 1 x 30 mg intact BiC given with high fat meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib | Drug | ritlecitinib 1 x 30 mg intact BiC (Treatment Arms A, E) ritlecitinib 1 x 30 mg intact BiC sprinkled on soft foods (Treatment Arms B, C, D) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib | AUCinf was defined as area under the plasma-concentration time profile from time zero extrapolated to infinite time. AUCinf for ritlecitinib was calculated by 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. | 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval. |
| Maximum Observed Concentration (Cmax) of Ritlecitinib | Cmax was defined as maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data. | 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state. |
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Key Inclusion Criteria:
Key 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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This is a phase 1, open-label, single dose, randomized 4-crossover periods (periods 1-4) and 1-fixed period (period 5) design study. A total of 12 participants were randomized and assigned to receive the study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Treatment A-> B-> C-> D-> E | Participants were randomized to receive ritlecitinib 30 milligram (mg) intact blend-in capsule (BiC) in fasted state on Day 1 of Period 1 (Treatment A). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib. |
| FG001 | Sequence 2: Treatment B-> D-> A-> C-> E | Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state on Day 1 of Period 1 (Treatment B). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib. |
| FG002 | Sequence 3: Treatment C-> A-> D-> B-> E | Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state on Day 1 of Period 1 (Treatment C). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib. |
| FG003 | Sequence 4: Treatment D-> C-> B-> A-> E | Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state on Day 1 of Period 1 (Treatment D). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib | AUCinf was defined as area under the plasma-concentration time profile from time zero extrapolated to infinite time. AUCinf for ritlecitinib was calculated by 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. | All participants randomized and treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval. |
|
From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)
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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 30 mg Capsule (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule under fasted conditions on Day 1 of each Period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA v26.0 | 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 | Feb 2, 2023 | Jun 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2023 | Jun 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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| From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days) |
| Number of Participants With Laboratory Abnormalities | Hematology included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy. Laboratory abnormalities were judged by the investigator. Laboratory abnormalities reported for at least 1 participant in the whole study are presented here. | From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 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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| COMPLETED |
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| NOT COMPLETED |
|
|
| Years |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ritlecitinib 30 mg Capsule (Fasted) |
Participants received a single oral dose of ritlecitinib 30 mg capsule under fasted conditions on Day 1 of each Period. |
| OG001 | Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with strawberry jam under fasted conditions on Day 1 of each Period. |
| OG002 | Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with yoghurt under fasted conditions on Day 1 of each Period. |
| OG003 | Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with applesauce under fasted conditions on Day 1 of each Period. |
| OG004 | Ritlecitinib 30 mg Capsule Given With High Fat Meal | Participants received a single oral dose of ritlecitinib 30 mg capsule given with high fat meal on Day 1 of each Period. |
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|
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| Primary | Maximum Observed Concentration (Cmax) of Ritlecitinib | Cmax was defined as maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data. | All participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval. |
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|
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| Secondary | Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state. | All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days) |
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|
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| Secondary | Number of Participants With Laboratory Abnormalities | Hematology included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy. Laboratory abnormalities were judged by the investigator. Laboratory abnormalities reported for at least 1 participant in the whole study are presented here. | All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days) |
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with strawberry jam under fasted conditions on Day 1 of each Period. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG002 | Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with yoghurt under fasted conditions on Day 1 of each Period. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG003 | Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) | Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with applesauce under fasted conditions on Day 1 of each Period. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG004 | Ritlecitinib 30 mg Capsule Given With High Fat Meal | Participants received a single oral dose of ritlecitinib 30 mg capsule given with high fat meal on Day 1 of each Period. | 0 | 10 | 0 | 10 | 2 | 10 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
|
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Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted) |
| Ratio (%) of Adjusted Geometric Means |
| 84.58 |
| 2-Sided |
| 90 |
| 73.23 |
| 97.70 |
| Other |
Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages. |
| Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted) | Ratio (%) of Adjusted Geometric Means | 93.91 | 2-Sided | 90 | 81.30 | 108.48 | Other | Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages. |
| Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal | Ratio (%) of Adjusted Geometric Means | 43.83 | 2-Sided | 90 | 37.50 | 51.23 | Other | Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages. |
| Number of participants with all-causality SAEs |
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| Number of participants with treatment-related TEAEs |
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| Number of participants with treatment-related SAEs |
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