Clinical trials: Palbociclib
Healthy
A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.
- Trial name
- NCT01953731
- Testing
- Palbociclib, Rifampin
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)
The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation.
- Trial name
- NCT01802476
- Testing
- Oral Drug Formulation of PD-0332991, Intravenous Formulation of PD-0332991
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately…
- Trial name
- NCT01756768
- Testing
- [14C]-PD-0332991
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption.
- Trial name
- NCT01844323
- Testing
- Palbociclib Formulation Reference, Palbociclib Formulation Test
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
- Trial name
- NCT02097329
- Testing
- palbociclib commercial free base, famotidine, rabeprazole
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)
This study is designed to evaluate the potential effect of the moderate CYP3A inducer modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.
- Trial name
- NCT02222441
- Testing
- Palbociclib alone, Palbociclib plus Modafinil, Palbociclib plus pioglitazone
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination 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…
- Trial name
- NCT01821066
- Testing
- PD-0332991 alone, Tamoxifen 60 mg, Tamoxifen 20 mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of…
- Trial name
- NCT06331715
- Testing
- Palbociclib 125mg
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Megalabs
Healthy
Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.
- Trial name
- NCT02131298
- Testing
- Palbociclib Alone, Palbociclib plus itraconazole
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole.
- Trial name
- NCT01918176
- Testing
- Palbociclib alone, Palbociclib + Rabeprazole
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
Study Of Palbociclib (PD-0332991) In Renal Impairment
Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib.
- Trial name
- NCT02085538
- Testing
- palbociclib
- Where
- 3 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.
This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg…
- Trial name
- NCT01756781
- Testing
- Midazolam, PD-0332991
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.
- Trial name
- NCT02311946
- Testing
- Palbociclib Alone, Palbociclib + Rabeprazole
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib…
- Trial name
- NCT02059330
- Testing
- Palbociclib 75mg, Palbociclib 125mg, Palbociclib 100mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
CYP3A4*22
Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype
The objective of this study is to estimate the effect of CYP3A4*22 on the clearance and area under the plasma concentration-time curve of Palbociclib, Ribociclib, and Abemaciclib
- Trial name
- NCT05691400
- Testing
- Palbociclib 125Mg Tab, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG Oral Tablet
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer, Breast Diseases
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.
- Conditions
- Breast Cancer, Breast Diseases, Breast Neoplasms
- Trial name
- PECP (NCT03756090)
- Testing
- Palbociclib, Epirubicin, Cyclophosphamide
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Zhejiang Cancer Hospital
Healthy Volunteer
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet formulation of palbociclib
- Trial name
- NCT03220191
- Testing
- Palbociclib, Rabeprazole
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Relative Bioavailability For Palbociclib Formulations
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution…
- Trial name
- NCT02083640
- Testing
- Palbociclib Formulation Reference, Palbociclib Formulation Test
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
- Trial name
- NCT02041273
- Testing
- palbociclib isethionate (phase 1 and 2 studies), palbociclib commercial free base capsule
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer