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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

Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE December 7, 2018
Actual Primary Completion Date January 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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 ]
  • number of subjects with significant change from baseline in laboratory safety tests results [ Time Frame: study days -1, 4, 13 post-dose ]
  • number of subjects with treatment emergent adverse events (TEAE) [ Time Frame: Baseline up to 35 days post dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ
Official Title  ICMJE 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
Brief Summary The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: midazolam/efavirenz
    Interventions:
    • Drug: midazolam
    • Drug: efavirenz
  • Experimental: PF-06651600/midazolam/efavirenz
    Interventions:
    • Drug: PF-06651600
    • Drug: midazolam
    • Drug: efavirenz
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date January 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762928
Other Study ID Numbers  ICMJE B7981017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP