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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762928
• Other study ID #: B7981017
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2018
• Est. completion date: February 21, 2019

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 21, 2019
• Est. primary completion date: January 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• PF-06651600
200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days
• midazolam
single administration of midazolam 2 mg oral solution
• efavirenz
single administration of efavirenz 50 mg capsule

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	single dose Area under the curve at last quantifiable infinity time of midazolam		Hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose
Primary	Single dose Area under the Curve from time 0 to 72 hours post-dose of efavirenz		hour 0, 0,5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose
Secondary	number of subjects with significant change from baseline in vital signs		hour 0 on study days 1, 4, 10 and 13 post-dose
Secondary	number of subjects with significant change from baseline in laboratory safety tests results		study days -1, 4, 13 post-dose
Secondary	number of subjects with treatment emergent adverse events (TEAE)		Baseline up to 35 days post dose

External Links

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