The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults

NCT ID: NCT03126721

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2017-07-11

Brief Summary

This is a drug interaction study to evaluate the PF-06751979 at steady state on the pharmacokinetics of oral midazolam single doses in fixed sequences including single dose midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for 11 days with single dose midazolam co-administered on Day 10 in period 2

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

oral midazolam alone

single dose of oral midazolam administered alone in period 1

Group Type: EXPERIMENTAL

midazolam

Intervention Type: DRUG

a single oral dose of 2 mg midazolam

oral midazolam administered with multiple doses of PF-06751979

single dose of midazolam on day 10 with multiple doses of PF-06751979 once a day on Days 1-11 in period 2

Group Type: EXPERIMENTAL

midazolam

Intervention Type: DRUG

a single oral dose of 2 mg midazolam

PF-06751979

Intervention Type: DRUG

multiple oral doses of PF-06751979 100 mg a day

Interventions

midazolam

a single oral dose of 2 mg midazolam

Intervention Type: DRUG

PF-06751979

multiple oral doses of PF-06751979 100 mg a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy female subjects of nonchildbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
• Subjects who have previously received PF-06751979.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
• Herbal supplements and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of hypersensitivity to midazolam or any other benzodiazapine.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Clinical Research Unit

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B8271007&StudyName=A+Phase+1%2C+Open-label%2C+Fixed-sequence+Design+Study+To+Assess+The+Effect+Of+Multiple+Dose+Administration+Of+Pf-06751979+On+The+Single+Dose+Pharmacokinetics+Of+Oral+Midazolam+In+Healthy+Adult+Subjects

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Other Identifiers

2016-004238-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B8271007

Identifier Type: -

Identifier Source: org_study_id