Clinical trial NCT04092595: A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
Official title: A PHASE 1, 2-PERIOD FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics (PK)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.


Eligibility criteria: Inclusion Criteria:

* Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
* Body mass index (BMI) of 17.5 to 30.5 kg/m sq, and a total body weight greater than 50 kg (110 lb.).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Participants with any of the following acute or chronic infections or infection history:
* Any infection requiring treatment within 2 weeks prior to the dosing visit.
* Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days of the first dose of rosuvastatin.
* Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of rosuvastatin.
* Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
* History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
* Known presence 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.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rosuvastatin
timeFrame: Period 1 (4 days) day 1 and period 2 (11 days) day 8 , 0 (pre-dose), 0.5, 1,2,3,4,5,6,8,10,12,16,24,36,48,and 72 hours post-dose
measure: Renal clearance (CLr) for rosuvastatin
timeFrame: Period 1 (4 days) day 1 and period 2 (11 days) day 8 , hours: [0-6], [6-12], [12-24], [24-48], and [48-72] post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brussels Clinical Research Unit
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: