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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 11, 2017

Primary Completion Date

November 15, 2017

Study Completion Date

November 15, 2017

Conditions
Healthy
Interventions
DRUG

10 mg dose MR formulations,10 mg dose of tofacitinib IR solution

"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."

Trial Locations (1)

06511

Pfizer New Haven Clinical Research Unit, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03112148 - PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations | Biotech Hunter | Biotech Hunter