A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

NCT04092595 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79810242019-002536-85
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

pharmacokinetics (PK)

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rosuvastatin

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  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

• Renal clearance (CLr) for rosuvastatin

  CLr = total amount of drug collected in urine (Ae) divided by area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast).

  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

Study Arms (1)

PF-06651600 and Rosuvastatin

EXPERIMENTAL

Period 1 is 4 days in length. On Day 1 of Period 1 participants will receive a single dose of Rosuvastatin 10 mg given as a tablet orally. Period 2 is 11 days in length and will immediately follow Period 1 with no washout. In Period 2, participants will be dosed with oral 200 mg PF-06651600 once-daily (QD) for 7 days. On Day 8 of Period 2, a single dose of 10 mg Rosuvastatin oral tablet will be administered following administration of the 200-mg dose of PF-06651600. Dosing with oral 200 mg PF-06651600 QD will continue until Day 10 of Period 2.

Drug: PF-06651600; Drug: Rosuvastatin

Interventions

PF-06651600 DRUG

PF-06651600: 200 mg dose provided as four 50 mg oral tablets

PF-06651600 and Rosuvastatin

Rosuvastatin DRUG

10 mg oral tablet

Also known as: Crestor ®

PF-06651600 and Rosuvastatin

Eligibility Criteria

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

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

PF-06651600; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 17, 2019
• Study Start: September 26, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)