Clinical Trials Logo
  1. Home
  2. Renal Impairment
  3. NCT02085538

Study Of Palbociclib (PD-0332991) In Renal Impairment

Renal Impairment Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02085538
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date May 2014
Completion date May 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03284164 - Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex Phase 1
Completed NCT05992155 - A Study of TAK-279 in Adults With or Without Kidney Problems Phase 1
Completed NCT05004311 - The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics Phase 1
Completed NCT04963738 - A Study of JNJ-73763989 in Adult Participants With Renal Impairment Phase 1
Terminated NCT02508740 - Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Phase 1
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Terminated NCT00984113 - Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00842868 - The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases N/A
Completed NCT00750620 - A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment Phase 1
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Completed NCT05489614 - A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment Phase 1
Completed NCT03259087 - Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005) Phase 1
Completed NCT05086107 - Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment Phase 1
Recruiting NCT05349851 - Bowel Cleansing With Renal Impairment
Completed NCT03660241 - A Renal Impairment Study for PF-04965842 Phase 1
Recruiting NCT06037031 - A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function Phase 1
Completed NCT03289208 - Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment Phase 1
Completed NCT02942810 - To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment Phase 1