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Janus Kinase (JAK) Inhibitor

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose in period 1 (days 1 and 2) and period 2 (days 10 and 11)
Awards & highlights

Summary

This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose in period 1 (days 1 and 2) and period 2 (days 10 and 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose in period 1 (days 1 and 2) and period 2 (days 10 and 11) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tolbutamide Administered With and Without Ritlecitinib
Maximum Plasma Concentration (Cmax) of Tolbutamide Administered With and Without Ritlecitinib
Secondary study objectives
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - All Causalities and Treatment Related

Side effects data

From 2022 Phase 1 trial • 12 Patients • NCT05097716
10%
Nail disorder
10%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Ritlecitinib
Period 2: Ritlecitinib + Tolbutamide
Period 1: Tolbutamide

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ritlecitinib and tolbutamideExperimental Treatment2 Interventions
In Period 1, participants will be dosed with a single administration of tolbutamide 500 mg tablet on Day 1. Period 1 will be immediately followed by Period 2 with no washout. In Period 2, participants will be dosed with oral 200 mg ritlecitinib QD for 10 days followed by administration of a single dose of 500 mg tolbutamide oral tablet within approximately 5 minutes after administration of a 200 mg dose of ritlecitinib on the morning of Day 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tolbutamide
2015
Completed Phase 1
~180
Ritlecitinib
2020
Completed Phase 1
~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,631 Previous Clinical Trials
17,733,322 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,523 Previous Clinical Trials
14,907,228 Total Patients Enrolled
~3 spots leftby Sep 2025
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