A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | August 2013 |
A Phase 1 Open-Label Fixed-Sequence Two-Period Crossover Study Of The Effect Of Multiple Doses Of Tamoxifen On PD-0332991 Pharmacokinetics In Healthy Male Volunteers
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered
alone and after steady-state dosing of tamoxifen to determine if coadministration of
tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
alone and after steady-state dosing of tamoxifen to determine if coadministration of
tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
Inclusion Criteria:
- Healthy male between the ages of 18 and 55 years of age inclusive
- Body mass index (BMI) between 17.5 and 30.5 kg/m2
- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures
Exclusion Criteria:
- a positive urine drug screen
- a supine systolic blood pressure >140 mm Hg, or diastolic blood pressure >90 mm H.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.
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