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NCT Number: NCT01756781

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 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

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.

PD-0332991

Drug

Treatment B includes 8 daily 125 mg oral doses of PD-0332991.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. Maximum Observed Plasma Midazolam Concentration (Cmax)

    Time frame: 0-36 hrs post midazolam dose

  3. Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)

    Time frame: 0-36 hrs post midazolam dose

  4. 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.

  5. Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991

    Time frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 27, 2012
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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