A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT04111614
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).

Key Dates

Start date
Oct 11, 2019
Status verified
Jan 2020
Primary completion
Dec 12, 2019
Completion
Dec 12, 2019

Study Design

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

Arms

  • Experimental: Arm 1
    Single dose of 5 mL tofacitinib oral solution on Day 1 of Period 1 and Singe dose of 5 mg tofacitinib tablet on Day 1 of Period 2
  • Experimental: Arm 2
    Single dose of 5 mg tofacitinib tablet on Day 1 of Period 1 and Singe dose of 5 mL tofacitinib oral solution on Day 1 of Period 2

Primary Outcome Measure

AUCinf for tofacitinib oral solution and tofacitinib tablet [ Time Frame: 24 hrs after study drug administration in Period 1 and Period 2 ]

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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