NCT02085538

Study Of Palbociclib (PD-0332991) In Renal Impairment

A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	palbociclib	palbociclib 125 mg oral capsule with food once
DRUG	palbociclib	palbociclib 125 mg oral capsule with food once
DRUG	palbociclib	palbociclib 125 mg oral capsule with food once
DRUG	palbociclib	palbociclib 125 mg oral capsule with food once

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-03-13
• Last updated: 2018-04-30

Locations

3 sites across 1 country: United States