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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Pfizer
Study ID
NCT03112148
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution — DRUG
    For the the relative bioavailability (BA) assessment , the investigational product(s) are: Test: 10 mg dose of age-appropriate MR formulations (MR-fast, MR-moderate, MR-slow). Each formulation contains 0.025 mg of tofacitinib/mg of microsphere. Reference: 10 mg dose of tofacitinib IR solution (1 mg of tofacitinib/mL). For the the food effect assessment, the investigational product(s) are: Test: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) c-oadministered with high-fat FDA breakfast. Reference: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) administered under fasted state.

Study Details

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.

Key Dates

Start date
Sep 11, 2017
Status verified
Jan 2018
Primary completion
Nov 15, 2017
Completion
Nov 15, 2017

Study Design

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

Arms

  • Experimental: Treatment A
    Single oral 10 mg dose of tofacitinib MR-FAST administered in the fed state.
  • Experimental: Treatment B:
    Single oral 10 mg dose of tofacitinib MR-SLOW administered in the fed state.
  • Experimental: Treatment C
    Single oral 10 mg dose of tofacitinib MR-FAST administered in the fasted state.
  • Experimental: Treatment D
    Single oral 10 mg dose of tofacitinib MR-SLOW administered in the fasted state.
  • Experimental: Treatment E
    Single oral 10 mg dose of tofacitinib MR-MODERATE administered in the fasted state
  • Experimental: 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

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
Pfizer New Haven Clinical Research UnitNew HavenConnecticut06511-

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