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Trial record 1 of 1 for:    NCT01756781
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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.

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ClinicalTrials.gov Identifier: NCT01756781
Recruitment Status : Completed
First Posted : December 27, 2012
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE December 27, 2012
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2012)
Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0-36hrs post midazolam dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2012)
  • Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0-36 hrs post midazolam dose ]
  • 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 ]
  • Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991 [ Time Frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Midazolam
    • Drug: 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.
    Interventions:
    • Drug: Midazolam
    • Drug: PD-0332991
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2012)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01756781
Other Study ID Numbers  ICMJE A5481012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP