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Janus Kinase (JAK) Inhibitor

Ritlecitinib 200 mg for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
Awards & highlights
No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Target Occupancy for BMX
Percent Target Occupancy for BTK
Percent Target Occupancy for ITK
+3 more
Secondary study objectives
Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib
Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib
+7 more

Side effects data

From 2022 Phase 1 trial • 16 Patients • NCT05128058
13%
Gastroenteritis viral
13%
Procedural dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
RITLECITINIB 200 MG CAPSULE
RITLECITINIB 50 MG CAPSULE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3
Group II: Cohort 1Experimental Treatment1 Intervention
Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib 50 mg
2021
Completed Phase 1
~20
Ritlecitinib 200 mg
2021
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,661 Previous Clinical Trials
17,844,973 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,886,129 Total Patients Enrolled
~4 spots leftby Dec 2025
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