A Midazolam Drug Interaction Study With PF-04171327

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00987038
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-04171327 25 mg; Drug: Midazolam 2 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: PF-04171327 and Midazolam	Drug: PF-04171327 25 mg; One 25 mg tablet administered once a day for 15 days; Drug: Midazolam 2 mg; Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15

Outcome Measures

Primary Outcome Measures

1. AUCinf of midazolam [17 days]

Secondary Outcome Measures

1. AUClast, Cmax, Tmax, t1/2 [17 days]

2. Vital Signs, Clinical Laboratory tests and Adverse Events [28 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 males and/or females (non-childbearing potential) volunteers.

• Cortisol level within normal reference range of the laboratory.

Exclusion Criteria:

• History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.

• History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.

• Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.

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.

• ClinicalTrials.gov Identifier: NCT00987038
• Other Study ID Numbers: A9391007
• First Posted: Sep 30, 2009
• Last Update Posted: Dec 8, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: drug interaction CYP3A4 glucocorticoids midazolam
• Additional relevant MeSH terms: Midazolam

Study Results

No Results Posted as of Dec 8, 2009