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The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03126721
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a drug interaction study to evaluate the PF-06751979 at steady state on the pharmacokinetics of oral midazolam single doses in fixed sequences including single dose midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for 11 days with single dose midazolam co-administered on Day 10 in period 2

Condition or disease Intervention/treatment Phase
Healthy Drug: midazolam Drug: PF-06751979 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-label, Fixed-sequence Design Study To Assess The Effect Of Multiple Dose Administration Of Pf-06751979 On The Single Dose Pharmacokinetics Of Oral Midazolam In Healthy Adult Subjects
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : July 11, 2017
Actual Study Completion Date : July 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oral midazolam alone
single dose of oral midazolam administered alone in period 1
Drug: midazolam
a single oral dose of 2 mg midazolam

Experimental: oral midazolam administered with multiple doses of PF-06751979
single dose of midazolam on day 10 with multiple doses of PF-06751979 once a day on Days 1-11 in period 2
Drug: midazolam
a single oral dose of 2 mg midazolam

Drug: PF-06751979
multiple oral doses of PF-06751979 100 mg a day




Primary Outcome Measures :
  1. midazolam Area Under the Curve from time 0 to last quantifiable concentration (AUClast) in Period 1 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose ]
    the plasma midazolam AUC from 0 to tlast (time of last quantifiable concentration) when a single oral midazolam dose given alone

  2. midazolam Cmax on Day 1 in Period 1 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose ]
    the midazolam Cmax when single oral midazolam dose given alone

  3. midazolam Area Under the Curve from time 0 to infinite (AUCinf) in Period 1 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose ]
    the plasma midazolam AUC from 0 to infinity when a single oral midazolam dose given alone

  4. midazolam AUClast in Period 2 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose ]
    the plasma midazolam AUC from 0 to tlast (time of the last quantifiable concentration) when a single oral midazolam given in presence of steady state PF-06751979

  5. midazolam Cmax in Period 2 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose ]
    the midazolam Cmax when a single oral midazolam given in presence of steady state PF-06751979

  6. midazolam AUCinf in Period 2 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose ]
    the plasma midazolam AUC from 0 to infinity when a single oral midazolam given in presence of steady state PF-06751979



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female subjects of nonchildbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
  • Subjects who have previously received PF-06751979.
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Herbal supplements and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of hypersensitivity to midazolam or any other benzodiazapine.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126721


Locations
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Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03126721    
Other Study ID Numbers: B8271007
2016-004238-50 ( EudraCT Number )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pfizer:
drug interaction
PF-06751979
oral midazolam
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action