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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

No Placebo-Only Group

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 weeks3 visits

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)

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%

Study treatment Arm

Period 2: Ritlecitinib

Period 1: Tolbutamide

Period 2: Ritlecitinib + Tolbutamide

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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