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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: midazolam; Drug: PF-06651600; Drug: efavirenz

• Registration Number: NCT03762928
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-04
• Study Start: 2018-12-07
• Primary Completion: 2019-01-27
• Study Completion: 2019-02-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
midazolam/efavirenz	midazolam	-
PF-06651600/midazolam/efavirenz	PF-06651600	-
midazolam/efavirenz	efavirenz	-
PF-06651600/midazolam/efavirenz	efavirenz	-
PF-06651600/midazolam/efavirenz	midazolam	-

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
number of subjects with significant change from baseline in vital signs	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	study days -1, 4, 13 post-dose
number of subjects with treatment emergent adverse events (TEAE)	Baseline up to 35 days post dose

Trial Locations

Locations (1)

Pfizer New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States