A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT04338711
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • tofacitinib modified release (MR) — DRUG
    Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state. Treatment F: a 10 mg oral dose of tofacitinib IR solution

Study Details

The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the lowest and higher levels of enteric coating will also be assessed.

Key Dates

Start date
Jun 17, 2020
Status verified
Oct 2020
Primary completion
Sep 15, 2020
Completion
Sep 15, 2020

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Single oral 10 mg dose of tofacitinib MR E1 administered in the fasted state.
  • Experimental: Treatment B
    Single oral 10 mg dose of tofacitinib MR E2 administered in the fasted state.
  • Experimental: Treatment C
    Single oral 10 mg dose of tofacitinib MR E3 administered in the fasted state.
  • Experimental: Treatment D
    Single oral 10 mg dose of tofacitinib MR E1 administered in the fed state.
  • Experimental: Treatment E
    Single oral 10 mg dose of tofacitinib MR E3 administered in the fed state.
  • Active Comparator: Treatment F
    Single oral 10 mg dose of tofacitinib IR Solution (10 mL of the 1 mg/mL solution) administered in the fasted state.

Primary Outcome Measure

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (AUCinf ) [ Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 9, 21, 24, 36, and 48 hours post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
New Haven Clinical Research UnitNew HavenConnecticut06511-

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New Haven Clinical Research Unit· New Haven, CT

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