- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
October 6, 2015 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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South Miami, Florida, United States, 33143
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Treatment B includes 8 daily 125 mg oral doses of PD-0332991.
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.
Treatment B is made up of 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.
|
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.
Treatment B includes 8 daily 125 mg oral doses of PD-0332991.
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.
Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0-36hrs post midazolam dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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0-36 hrs post midazolam dose
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Maximum Observed Plasma Midazolam Concentration (Cmax)
Time Frame: 0-36 hrs post midazolam dose
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0-36 hrs post midazolam dose
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Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)
Time Frame: 0-36 hrs post midazolam dose
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0-36 hrs post midazolam dose
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Plasma Decay Half-Life (t1/2) of Midazolam
Time Frame: 0-36 hrs post midazolam dose
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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0-36 hrs post midazolam dose
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Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991
Time Frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose
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Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
December 20, 2012
First Submitted That Met QC Criteria
December 26, 2012
First Posted (Estimate)
December 27, 2012
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antineoplastic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Protein Kinase Inhibitors
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
- Palbociclib
Other Study ID Numbers
- A5481012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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