← Back to Search

Other

Ritlecitinib 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
BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Awards & highlights

Summary

"This trial aims to understand how a medication called ritlecitinib moves through the intestines of healthy adult men when taken with or without food. Healthy male volunteers over 18 years old with a

Who is the study for?
This trial is for healthy male adults who are at least 18 years old, with a BMI of 16-32 kg/m2 and weigh more than 99 pounds. They must be in good health as confirmed by medical checks, able to consent to the study, and follow all procedures.
What is being tested?
The study tests how Ritlecitinib is absorbed in two forms: solution without food and capsule with or without food. Participants will stay at the clinic for about 11 days over three periods, taking doses followed by blood tests.
What are the potential side effects?
As this trial involves healthy individuals and not patients, side effects are monitored but not specified here. Typically, they could include reactions at the dose site or general symptoms like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 16 and 32, and I weigh more than 99 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Colon (ascending, transverse, descending) residence/transit time
Colon arrival time
Gastric emptying time
+3 more
Secondary outcome measures
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Frequency of abnormal 12-lead ECG
+6 more

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT05097716
8%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 1: Tolbutamide
Period 2: Ritlecitinib
Period 2: Ritlecitinib + Tolbutamide

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Sequence 2Experimental Treatment1 Intervention
Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 3).
Group II: Treatment Sequence 1Experimental Treatment1 Intervention
Ritlecitinib 100 mg solution (fasted, Period 1), followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fasted, Period 2), and followed by ritlecitinib 100 mg MR capsule with 153Sm2O3 (fed, Period 3).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib
2020
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,304,786 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,479,362 Total Patients Enrolled
~8 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top