ESTIMATION OF THE EFFECT OF MULTIPLE DOSE PF-06651600 ON... | NCT03762928

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

NCT03762928

Sponsor

Pfizer

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

PF-06651600
midazolam
efavirenz

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2018Actual

Primary Completion Date

Jan 27, 2019Actual

Completion Date

Feb 21, 2019Actual

First Submitted Date

Nov 30, 2018

First Submission Date that Met QC Criteria

Nov 30, 2018

First Posted Date

Dec 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2019

Last Update Posted Date

Mar 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
midazolam/efavirenz	Experimental		Drug: midazolam Drug: efavirenz
PF-06651600/midazolam/efavirenz	Experimental		Drug: PF-06651600 Drug: midazolam Drug: efavirenz

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-06651600	Drug	200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days	PF-06651600/midazolam/efavirenz

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer New Haven Clinical Research Unit		New Haven	Connecticut	06511	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000614924	PF-06651600
D008874	Midazolam
C098320	efavirenz

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided