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

NCT05852340 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: B79810782022-502872-22-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Adult; Pharmacokinetics

Keywords

Adult; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs)

  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

  From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)

Study Arms (5)

Treatment A

ACTIVE COMPARATOR

ritlecitinib 1 x 30 milligram (mg) intact blend-in-capsule (BiC) in fasted state

Drug: Ritlecitinib

Treatment B

ACTIVE COMPARATOR

contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on strawberry jam in fasted state

Drug: Ritlecitinib

Treatment C

ACTIVE COMPARATOR

contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on yoghurt in fasted state

Drug: Ritlecitinib

Treatment D

ACTIVE COMPARATOR

contents of ritlecitinib 1 x 30 mg intact BiC sprinkled on applesauce in fasted state

Drug: Ritlecitinib

Treatment E

ACTIVE COMPARATOR

ritlecitinib 1 x 30 mg intact BiC given with high fat meal

Drug: Ritlecitinib

Interventions

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)

Also known as: PF-06651600

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• 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).
• Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency, or infections (acute or chronic).

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: Yes

Study Design

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

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: May 9, 2023
• Primary Completion: June 15, 2023
• Study Completion: July 24, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)