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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT03762928

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 7, 2018

Actual Primary Completion Date :

Jan 27, 2019

Actual Study Completion Date :

Feb 21, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT03762928

Other Study ID Numbers:

B7981017

First Posted:

Dec 4, 2018

Last Update Posted:

Mar 26, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pfizer

Phase 1

Additional relevant MeSH terms:

Efavirenz

Midazolam

Study Results

No Results Posted as of Mar 26, 2019