A Target Occupancy Study With Ritlecitinib.

Plain-language summary

This is a study, sponsored by Pfizer, that assesses how much of the drug Ritlecitinib binds to its target in the body (target occupancy). It enrolled generally healthy adult women and men who met certain body-mass index criteria. The study was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Pfizer

Intervention

Ritlecitinib 50 mg, Ritlecitinib 200 mg

Start date

10/22/2021

Estimated completion

1/14/2022

Countries

United States

Related genes

Locations

• New Haven, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.