A Target Occupancy Study With Ritlecitinib.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ritlecitinib 200 mg; Drug: Ritlecitinib 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05128058

B7981045

Details and patient eligibility

About

This is a phase 1, open label, two-arm study to assess target occupancy and functional inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants are eligible to be included in the study only if all the following criteria apply:

• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination including BP and pulse rate measurement, 12-lead ECG, or clinical and laboratory tests.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• 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).
• Infection with HIV, hepatitis B or hepatitis C viruses
• Have evidence of untreated or inadequately treated active or latent Mycobacterium TB infection
• Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
• Have received only one of the 2 required doses of COVID-19 vaccine.
• Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3

Treatment:

Drug: Ritlecitinib 50 mg

Cohort 2

Experimental group

Description:

Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3

Treatment:

Drug: Ritlecitinib 200 mg