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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03762928

Enrollment

Registered

2018-12-04

Start date

2018-12-07

Completion date

2019-02-21

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

PK, Phase 1

Brief summary

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

Interventions

DRUGPF-06651600

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

DRUGmidazolam

single administration of midazolam 2 mg oral solution

DRUGefavirenz

single administration of efavirenz 50 mg capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	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

Measure	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
number of subjects with treatment emergent adverse events (TEAE)	Baseline up to 35 days post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026