Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT05097716
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ritlecitinib — DRUG
    Ritlecitinib 200 mg provided as four 50 mg oral capsules
  • Tolbutamide — DRUG
    Tolbutamide 500 mg provided as one 500 mg oral tablet

Study Details

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.

Key Dates

Start date
Nov 2, 2021
Status verified
Dec 2022
Primary completion
Jan 10, 2022
Completion
Jan 10, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ritlecitinib and tolbutamide
    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.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Tolbutamide Administered With and Without Ritlecitinib [ Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, and 36 hours post-dose of tolbutamide in Period 1 (Days 1 and 2) and Period 2 (Days 10 and 11) ]

Locations (1)

FacilityCityStateZIPSite coordinators
New Haven Clinical Research UnitNew HavenConnecticut06511-

Find similar trials in New Haven, CT

By research site
New Haven Clinical Research Unit· New Haven, CT

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