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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03762928
Pfizer
Not yet recruiting
ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ

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ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON THE PHARMACOKINETICS OF SINGLE DOSE MIDAZOLAM AND EFAVIRENZ
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
The current study will estimate any inhibitive or inductive effect of PF-06651600 on the pharmacokinetics of midazolam and efavirenz.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Subjects
  • 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
  • Experimental: midazolam/efavirenz
    Interventions:
    • Drug: midazolam
    • Drug: efavirenz
  • Experimental: PF-06651600/midazolam/efavirenz
    Interventions:
    • Drug: PF-06651600
    • Drug: midazolam
    • Drug: efavirenz
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
Same as current
April 4, 2019
April 4, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03762928
B7981017
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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