A Midazolam Drug Interaction Study With PF-04171327

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-04171327 25 mg; Drug: Midazolam 2 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987038

A9391007

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

PF-04171327 and Midazolam

Other group

Treatment:

Drug: Midazolam 2 mg

Drug: PF-04171327 25 mg