drugset / Trial / NCT02319148
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
RandomizedCrossoverOpen-labelBasic science
Summary
The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.
Timeline
- Start
- 2014-07
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diltiazem | Small molecule | 240 mg | — |
| Subject | Itraconazole | Small molecule | 200 mg | — |
| Subject | PF-00489791 | Small molecule | 20 mg | — |
| Subject | Verapamil | Other / unclassified | 240 mg | — |
Indications
No indication recorded.