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

NCT03762928 | Completed Phase 1 FDA Drug

• 1 other identifier: B7981017
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

PK; Phase 1

Outcome Measures

Primary Outcomes (2)

• 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 (3)

• 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

Study Arms (2)

midazolam/efavirenz

EXPERIMENTAL

Drug: midazolam; Drug: efavirenz

PF-06651600/midazolam/efavirenz

EXPERIMENTAL

Drug: PF-06651600; Drug: midazolam; Drug: efavirenz

Interventions

PF-06651600 DRUG

200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days

PF-06651600/midazolam/efavirenz

midazolam DRUG

single administration of midazolam 2 mg oral solution

PF-06651600/midazolam/efavirenz; midazolam/efavirenz

efavirenz DRUG

single administration of efavirenz 50 mg capsule

PF-06651600/midazolam/efavirenz; midazolam/efavirenz

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

PF-06651600; Midazolam; efavirenz

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: December 7, 2018
• Primary Completion: January 27, 2019
• Study Completion: February 21, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)