CP-690,550 and Midazolam Drug-Drug Interaction Study

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00902460

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

25.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: midazolam; CP-690,550 + midazolam Drug: CP-690,550 + midazolam; midazolam	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Sequence 1	Drug: midazolam; CP-690,550 + midazolam Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID
Experimental: Treatment Sequence 2	Drug: CP-690,550 + midazolam; midazolam Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone

Arm

Intervention/Treatment

Experimental: Treatment Sequence 1

Drug: midazolam; CP-690,550 + midazolam

Period 1 : 2 mg midazolam oral syrup alone Period 2: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID

Experimental: Treatment Sequence 2

Drug: CP-690,550 + midazolam; midazolam

Period 1: 2 mg midazolam oral syrup plus 30 mg CP-690,550 after 6 days of CP-690,550 at 30 mg BID Period 2: 2 mg midazolam oral syrup alone

Outcome Measures

Primary Outcome Measures

AUCinf of midazolam [10 Days]

Secondary Outcome Measures

AUClast, Cmax, Tmax, t1/2 of midazolam [10 Days]
Vital signs, laboratory tests and adverse events [10 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and/or female (non-child bearing potential) subjects

Exclusion Criteria:

Clinically significant infections within the past 3 months
History of previously untreated infection with Mycobacterium tuberculosis
Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00902460

Other Study ID Numbers:

A3921059

First Posted:

May 15, 2009

Last Update Posted:

Aug 13, 2009

Last Verified:

Aug 1, 2009

Keywords provided by , ,

drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents

Additional relevant MeSH terms:

Midazolam

Tofacitinib

Study Results

No Results Posted as of Aug 13, 2009