A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05040295
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate for approximately 2.5 months.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: ritlecitinib; Drug: ritlecitinib; Drug: ritlecitinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PEDIATRIC RITLECITINIB (PF-06651600) CAPSULES AND SPRAY CONGEALED BEADS RELATIVE TO ADULT CAPSULES IN HEALTHY ADULT PARTICIPANTS
• Actual Study Start Date: Sep 10, 2021
• Actual Primary Completion Date: Nov 19, 2021
• Actual Study Completion Date: Nov 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment sequence 1 Treatment sequence 1 will receive a single 30 milligrams (mg) ritlecitinib intact adult capsule during the first period, three 10 mg ritlecitinib pediatric capsules during the second period and 30 mg ritlecitinib spray congealed beads in the third period.	Drug: ritlecitinib; 30 mg intact adult capsule; Drug: ritlecitinib; 10 mg pediatric capsule; Drug: ritlecitinib; 30 mg spray congealed beads
Experimental: Treatment Sequence 2 Treatment sequence 2 will receive three 10 mg ritlecitinib pediatric capsules during the first period, a single 30 mg intact adult capsule during the second period and 30 mg ritlecitinib spray congealed beads in the third period.	Drug: ritlecitinib; 30 mg intact adult capsule; Drug: ritlecitinib; 10 mg pediatric capsule; Drug: ritlecitinib; 30 mg spray congealed beads

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf) for ritlecitinib [Day 1 pre-dose (hour 0) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and Day 2 at 24 hours post-dose in periods 1-3.]

2. Maximum Plasma Concentration (Cmax) for ritlecitinib [Day 1 pre-dose (hour 0) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and Day 2 at 24 hours post-dose in periods 1-3.]

Secondary Outcome Measures

1. Number of participants with clinically significant abnormalities in clinical laboratory values [Baseline through Day 6]

2. Incidence of treatment-emergent adverse events (AEs) [Baseline through Day 40]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete (full) physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.

• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

• Known immunodeficiency disorder, including positive serology for HIV at screening, or a first degree relative with a hereditary immunodeficiency

• Infection with hepatitis B or hepatitis C viruses.

• History of any lymphoproliferative disorder

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05040295
• Other Study ID Numbers: B7981030
• First Posted: Sep 10, 2021
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 24, 2022