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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03762928
Other study ID # B7981017
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 7, 2018
Est. completion date February 21, 2019

Study information

Verified date March 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 21, 2019
Est. primary completion date January 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PF-06651600
200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days
midazolam
single administration of midazolam 2 mg oral solution
efavirenz
single administration of efavirenz 50 mg capsule

Locations

Country Name City State
United States Pfizer New Haven Clinical Research Unit New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 number of subjects with significant change from baseline in vital signs hour 0 on study days 1, 4, 10 and 13 post-dose
Secondary number of subjects with significant change from baseline in laboratory safety tests results study days -1, 4, 13 post-dose
Secondary number of subjects with treatment emergent adverse events (TEAE) Baseline up to 35 days post dose
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