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

NCT05040295 | Completed Phase 1 Results FDA Drug

• 1 other identifier: B7981030
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for Ritlecitinib

  Plasma AUCinf for ritlecitinib is reported. AUCinf was calculated as \[AUClast+(Clast\*/kel)\], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, and 24 hours post dose on Day 1 in each period

• Maximum Plasma Concentration (Cmax) for Ritlecitinib

  Plasma Cmax for ritlecitinib is reported.

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, and 24 hours post dose on Day 1 in each period

Secondary Outcomes (2)

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

  Post first dose of study intervention on Period 1 Day 1 up to 35 days post last dose of study intervention on Period 3 Day 1 (maximum of 40 days)

• Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

  Baseline up to Period 3 Day 2 (maximum of 7 days)

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

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

Treatment Sequence 2

EXPERIMENTAL

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

Interventions

ritlecitinib DRUG

30 mg intact adult capsule

Treatment Sequence 2; Treatment sequence 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.

  PMID: 38267790 DERIVED

Related Links

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

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: September 10, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)