A Target Occupancy Study With Ritlecitinib.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05128058
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Ritlecitinib 50 mg; Drug: Ritlecitinib 200 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Oct 22, 2021
• Actual Primary Completion Date: Jan 14, 2022
• Actual Study Completion Date: Jan 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3	Drug: Ritlecitinib 50 mg; 50 mg single dose; Other Names: PF-06651600
Experimental: Cohort 2 Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3	Drug: Ritlecitinib 200 mg; 200 mg single dose; Other Names: PF-06651600

Outcome Measures

Primary Outcome Measures

1. Percent Target Occupancy (TO) [Predose, 1 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

   Percent for Janus Kinase 3 (JAK3) and Tyrosine kinase Expressed in hepatocellular Carcinoma (TEC)

Secondary Outcome Measures

1. Maximum Plasma Concentration (Cmax) of Ritlecitinib [Day 1]

   Cmax will be observed directly from data.

2. Time to Maximum Plasma Concentration (Tmax) of Ritlecitinib [Day 1]

   Tmax will be observed directly from data.

3. Plasma concentration at 48 hours post-dose (Clast) of Ritlecitinib [48 hours post dose]

   Clast will be observed directly from data.

4. Average plasma concentration from time 0 to 24 hrs (Cav) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, and 24 hr post dose]

   Calculated as area under the concentration time curve over the dosing frequency

5. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

   Area under the plasma concentration-time curve from time 0 to 24 hours (dosing frequency)

6. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of Ritlecitinib [Predose, 1 hr, 2 hr, 4 hr, 8 hr, 24 hr, and 48 hr post dose]

   Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Clast)

7. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline (Day 0) up to 28 days after last dose of study drug]

8. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline through study completion, approximately 3 days]

9. Number of Participants With Categorical Vital Signs Data [Baseline through study completion, approximately 3 days]

10. Number of Adverse Events by Severity [Baseline up to 28 days after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05128058
• Other Study ID Numbers: B7981045
• First Posted: Nov 19, 2021
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 22, 2022