Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
NCT01163851
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
- BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.
- History of a cardiovascular event (e.g., MI ) during the past year.
- Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled
diabetes is defined as HBIAc >9%).
- Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic
blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm
Hg, even with treatment). Subjects who have hypertension and are controlled on stable
dosages of anti-hypertensive medications can be included.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Birmingham, Alabama
- Garden Grove, California
- Garden Grove, California
- Long Beach, California
- Wildomar, California
- Clearwater, Florida
- DeLand, Florida
- Miami, Florida
- Orlando, Florida
- Atlanta, Georgia
- Overland Park, Kansas
- Overland Park, Kansas
- Overland Park, Kansas
- Kansas City, Missouri
- Kansas City, Missouri
- Saint Louis, Missouri
- Raleigh, North Carolina
- Raleigh, North Carolina
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Duncansville, Pennsylvania
- Greer, South Carolina
- Kingsport, Tennessee
- Houston, Texas
- Tomball, Texas
- Orem, Utah
- Richmond, Virginia
- Kelowna, British Columbia
- Chicoutimi, Quebec
- Laval, Quebec
- Montreal, Quebec
- Sherbrooke, Quebec
- Quebec,
- Tustin, California
- Walnut Creek, California
- Clearwater, Florida
- DeLand, Florida
- Doral, Florida
- Jacksonville, Florida
- Miami, Florida
- Woodstock, Georgia
- Woodstock, Georgia
- Overland Park, Kansas
- Wichita, Kansas
- Louisville, Kentucky
- Madisonville, Kentucky
- Auburn, Maine
- North Dartmouth, Massachusetts
- Kansas City, Missouri
- Kansas City, Missouri
- Kansas City, Missouri
- Saint Louis, Missouri
- Albuquerque, New Mexico
- Raleigh, North Carolina
- Salisbury, North Carolina
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Duncansville, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Spartanburg, South Carolina
- Knoxville, Tennessee
- Knoxville, Tennessee
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- Norfolk, Virginia
- Richmond, Virginia
- Kelowna, British Columbia
- Chicoutimi, Quebec
- Laval, Quebec
- Montreal, Quebec
- Sherbrooke, Quebec
- Quebec,
- Peoria, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Overland Park, Kansas
- Overland Park, Kansas
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin | |||
Official Title ICMJE | A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Rn316 In Combination With Atorvastatin In Hypercholesterolemic Subjects | |||
Brief Summary | The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: PF-04950615 (RN316)
Interventions:
| |||
Publications * | Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 25 | |||
Original Estimated Enrollment ICMJE | 20 | |||
Actual Study Completion Date ICMJE | April 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01163851 | |||
Other Study ID Numbers ICMJE | B1481003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |