A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) SPRINKLED IN APPLESAUCE, YOGHURT AND STRAWBERRY JAM RELATIVE TO INTACT BLEND-IN CAPSULE OF RITLECITINIB AND THE EFFECT OF FOOD ON THE BIOAVAILABILITY OF THE INTACT BLEND-IN CAPSULE DOSAGE FORMULATION OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS

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:

• aged 18 or older;
• male or female who are healthy as determined by medical assessment ;
• Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics; Adult
• Intervention / Treatment: Drug: Ritlecitinib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Aged 18 or older.
2. Male or female who are healthy as determined by medical assessment.
3. Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

Key Exclusion Criteria:

1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
3. Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency, or infections (acute or chronic).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment A; ritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state	Drug: Ritlecitinib; 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); Other Names: PF-06651600
Active Comparator: Treatment B; contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state	Drug: Ritlecitinib; 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); Other Names: PF-06651600
Active Comparator: Treatment C; contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state	Drug: Ritlecitinib; 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); Other Names: PF-06651600
Active Comparator: Treatment D; contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state	Drug: Ritlecitinib; 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); Other Names: PF-06651600
Active Comparator: Treatment E; ritlecitinib 1 x 30 mg intact BiC given with high fat meal	Drug: Ritlecitinib; 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); Other Names: PF-06651600

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	Maximum plasma concentration, or Cmax, will be calculated from PK concentrations.	Days 1, 3, 5, 7 and 9 (pre-dose (Hour 0) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose)
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)	Area under the plasma concentration-time profile from time zero extrapolated to infinite time, or AUCinf, will be calculated from PK concentrations.	Days 1, 3, 5, 7 and 9 (pre-dose (Hour 0) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, and 24 hours postdose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting adverse events	To evaluate the safety and tolerability of 30 mg BiCs of ritlecitinib administered to healthy adult participants under fasted and fed conditions	Baseline up to 35 days after last dose (Day 44)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 24, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adult; Pharmacokinetic
• Other Study ID Numbers: B7981078; 2022-502872-22-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No