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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 study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756781
First Posted: December 27, 2012
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 doses of PD-0332991. Volunteers will be randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in treatment period 1, and following a washout period of no less than 14 days they will receive midazolam alone in treatment period 2.

Condition Intervention Phase
Healthy Drug: Midazolam Drug: PD-0332991 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Randomized, Open-Label, 2-Sequence, 2-Period Crossover Study Of The Effect Of Multiple Doses Of PD-0332991 On Midazolam Pharmacokinetics In Healthy Women of Non-Childbearing Potential

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0-36hrs post midazolam dose ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).


Secondary Outcome Measures:
  • Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0-36 hrs post midazolam dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • Maximum Observed Plasma Midazolam Concentration (Cmax) [ Time Frame: 0-36 hrs post midazolam dose ]
  • Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax) [ Time Frame: 0-36 hrs post midazolam dose ]
  • Plasma Decay Half-Life (t1/2) of Midazolam [ Time Frame: 0-36 hrs post midazolam dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991 [ Time Frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose ]

Enrollment: 26
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Subjects randomized to Sequence 1 will receive Treatment A followed by Treatment B. Treatment A is a single 2 mg oral dose of midazolam alone. Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.
Drug: Midazolam
Treatment A includes a single 2 mg oral dose of midazolam alone. Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.
Drug: PD-0332991
Treatment B includes 8 daily 125 mg oral doses of PD-0332991.
Experimental: Sequence 2
Subjects randomized to Sequence 2 will receive Treatment B followed by Treatment A with a washout of no less than 14 days in between.Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. There will be a minimum washout of 14 days prior to beginning Treatment A. Treatment A is a single 2 mg oral dose of midazolam alone.
Drug: Midazolam

Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.

Treatment A includes a single 2 mg oral dose of midazolam alone.

Drug: PD-0332991
Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females of non-child bearing potential between the ages of 18 and 65 years old.
  • A Body Mass Index (BMI) of 17.5 to 32.0 kg/m2 and a total body weight >50 kg (110 lbs).
  • A signed informed consent document.

Exclusion Criteria:

  • Any evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • A positive urine drug screen.
  • Pregnant or nursing females.
  • Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of study medication.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756781


Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01756781     History of Changes
Other Study ID Numbers: A5481012
First Submitted: December 20, 2012
First Posted: December 27, 2012
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by Pfizer:
PD-0332991
Midazolam
Drug-Drug Interaction Study
Healthy Adult Volunteer

Additional relevant MeSH terms:
Midazolam
Palbociclib
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors