A Target Occupancy Study With Ritlecitinib.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2022-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Telitacicept on Antibody Titers in Primary APS Patients

NCT06315530

Antiphospholipid Syndrome (APS)

COMPLETED PHASE2

Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan

NCT07216079

Immune Thrombocytopenia

ACTIVE_NOT_RECRUITING PHASE3

A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

NCT03395210

Immune Thrombocytopenia

ACTIVE_NOT_RECRUITING PHASE2

A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

NCT02137681

Immune Thrombocytopenia

WITHDRAWN PHASE3

Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia

NCT05446831

ITP Immune Thrombocytopenia

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

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

Group Type EXPERIMENTAL

Ritlecitinib 50 mg

Intervention Type DRUG

50 mg single dose

Cohort 2

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

Group Type EXPERIMENTAL

Ritlecitinib 200 mg

Intervention Type DRUG

200 mg single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ritlecitinib 50 mg

50 mg single dose

Intervention Type DRUG

Ritlecitinib 200 mg

200 mg single dose

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PF-06651600 PF-06651600

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes