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ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03762928
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: PF-06651600 Drug: midazolam Drug: efavirenz Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ IN HEALTHY PARTICIPANTS
Actual Study Start Date : December 7, 2018
Actual Primary Completion Date : January 27, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: midazolam/efavirenz Drug: midazolam
single administration of midazolam 2 mg oral solution

Drug: efavirenz
single administration of efavirenz 50 mg capsule

Experimental: PF-06651600/midazolam/efavirenz Drug: PF-06651600
200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days

Drug: midazolam
single administration of midazolam 2 mg oral solution

Drug: efavirenz
single administration of efavirenz 50 mg capsule




Primary Outcome Measures :
  1. single dose Area under the curve at last quantifiable infinity time of midazolam [ Time Frame: Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose ]
  2. Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz [ Time Frame: hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose ]

Secondary Outcome Measures :
  1. number of subjects with significant change from baseline in vital signs [ Time Frame: hour 0 on study days 1, 4, 10 and 13 post-dose ]
  2. number of subjects with significant change from baseline in laboratory safety tests results [ Time Frame: study days -1, 4, 13 post-dose ]
  3. number of subjects with treatment emergent adverse events (TEAE) [ Time Frame: Baseline up to 35 days post dose ]


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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:

Male and female participants who are healthy Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
  • Any condition possibly affecting drug absorption
  • Known immunodeficiency.
  • Infection with hepatitis B or hepatitis C viruses
  • acute or chronic infections or infection history judged to be clinically significant by the investigator
  • History of any lymphoproliferative disorder
  • known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.

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): NCT03762928


Locations
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United States, Connecticut
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
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: NCT03762928     History of Changes
Other Study ID Numbers: B7981017
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/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

Keywords provided by Pfizer:
PK
Phase 1

Additional relevant MeSH terms:
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Efavirenz
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers