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.

NCT01756781 | Completed Phase 1

• 1 other identifier: A5481012
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

PD-0332991; Midazolam; Drug-Drug Interaction Study; Healthy Adult Volunteer

Outcome Measures

Primary Outcomes (1)

• Midazolam Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  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 Outcomes (5)

• Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0-36 hrs post midazolam dose

• Maximum Observed Plasma Midazolam Concentration (Cmax)

  0-36 hrs post midazolam dose

• Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax)

  0-36 hrs post midazolam dose

• Plasma Decay Half-Life (t1/2) of Midazolam

  0-36 hrs post midazolam dose

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

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

Study Arms (2)

Sequence 1

EXPERIMENTAL

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; Drug: PD-0332991

Sequence 2

EXPERIMENTAL

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; Drug: PD-0332991

Interventions

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.

Sequence 1

PD-0332991 DRUG

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

Sequence 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Midazolam; palbociclib

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)