A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults

NCT06172348 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: B79810862023-505603-23-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Aged 18 years or older;
• male or female who are healthy as determined by medical assessment;
• BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb). 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Adults

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

  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)

  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

  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

  From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days)

Study Arms (6)

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)

Drug: Ritlecitinib

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)

Drug: Ritlecitinib

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)

Drug: Ritlecitinib

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)

Drug: Ritlecitinib

Treatment Sequence 5

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 2 (fed, Period 4)

Drug: Ritlecitinib

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)

Drug: Ritlecitinib

Interventions

Ritlecitinib DRUG

Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg)

Also known as: PF-06651600

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Capable of giving signed informed consent

You may not qualify if:

• 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).
• Participants with the acute or chronic infections or infection history
• History of febrile illness within 5 days prior to the first dose of study intervention.
• History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
• Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• History of active or latent Mycobacterium TBA: participant who is currently being treated for active or latent Mycobacterium TB infection or has a history of Mycobacterium TB must be excluded from the study.
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

PF-06651600

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2024
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)