A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of PD-0332991 To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.
This study is not yet open for participant recruitment.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01756781
First received: December 20, 2012
Last updated: April 23, 2013
Last verified: April 2013
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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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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:
MedlinePlus related topics:
Drug Reactions
Drug Information available for:
Midazolam hydrochloride
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Midazolam Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0-36 hrs post midazolam dose ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Midazolam Concentration (Cmax) [ Time Frame: 0-36 hrs post midazolam dose ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma Midazolam Concentration (Tmax) [ Time Frame: 0-36 hrs post midazolam dose ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) of Midazolam [ Time Frame: 0-36 hrs post midazolam dose ] [ Designated as safety issue: No ]
- Minimum Observed Plasma Trough Concentration (Cmin) of PD-0332991 [ Time Frame: Prior to the 6th, 7th, and 8th oral daily PD-0332991 dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 26 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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. Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01756781 History of Changes |
| Other Study ID Numbers: | A5481012 |
| Study First Received: | December 20, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
PD-0332991 Midazolam Drug-Drug Interaction Study Healthy Adult Volunteer |
Additional relevant MeSH terms:
|
Midazolam Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013