A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731327
• Other study ID #: A3921132
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2012
• Last updated: December 20, 2012
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects and/or healthy female subjects who are of non-childbearing potential.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;

• Clinically significant infections within the past 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• tofacitinib modified-release (MR) formulation
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
• tofacitinib modified-release (MR) formulation
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized		72 hours post dose	No
Primary	Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized		72 hours post dose	No
Secondary	AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized		72 hours post dose	No
Secondary	AUCinf: Area Under the Curve From Time Zero to Infinity		72 hours post dose	No
Secondary	Cmax: Maximum Observed Plasma Concentration		72 hours post dose	No
Secondary	AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration		72 hours post dose	No
Secondary	Tmax: Amount of time drug takes to reach Cmax		72 hours post dose	No
Secondary	t ½: Terminal elimination half-life		72 hours post dose	No

External Links

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