Clinical trial NCT05128058: A Target Occupancy Study With Ritlecitinib.
Official title: AN OPEN LABEL, PHASE 1, TWO-ARM STUDY TO ASSESS TARGET OCCUPANCY AND FUNCTIONAL INHIBITION OF JAK3 AND TEC KINASES BY SINGLE DOSES OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Target Occupancy for JAK3
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Percent Target Occupancy for BTK
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Percent Target Occupancy for ITK
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Percent Target Occupancy for TXK
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Percent Target Occupancy for TEC
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Percent Target Occupancy for BMX
timeFrame: -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Last Quantifiable Plasma Concentration (Clast) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
measure: Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib
timeFrame: 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose
measure: Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)
measure: Number of Participants With Treatment-Emergent Adverse Events by Severity
timeFrame: From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)
measure: Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
timeFrame: From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)
measure: Number of Participants With Pre-defined Criteria for Vital Signs
timeFrame: From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: