CompletedInterventionalPhase 1Last updated Jan 23, 2018

PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics And Safety Of Three Age-appropriate Modified Release Formulations And The Immediate Release Solution Of Tofacitinib In Healthy Adult Volunteers

Overview

ClinicalTrials.gov ID: NCT03112148
Lead Sponsor: PfizerINDUSTRY
Brief Summary: This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.
Study Type

Status

Overall Status: Completed
Start Date: Sep 11, 2017Actual
Primary Completion Date: Nov 15, 2017Actual
Completion Date: Nov 15, 2017Actual

Study Record Dates

First Submitted: Apr 7, 2017
First Submitted that Met QC Criteria: Apr 7, 2017
First Posted: Apr 13, 2017Actual
Last Update Submitted that Met QC Criteria: Jan 20, 2018
Last Update Posted: Jan 23, 2018Actual
Last Verified: Jan 2018

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