Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

Back to Search
Print
Bookmark Trial

NCT01163851

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Premier Research Group, Limited
Peoria, Arizona, 85381, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

ClinicalTrials.gov_Inquiries[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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.

Advanced Search

Based on your search, you may also be interested in

Hypercholesterolemia, DyslipidemiaA Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
NCT01350141
  1. Birmingham, Alabama
  2. Garden Grove, California
  3. Garden Grove, California
  4. Long Beach, California
  5. Wildomar, California
  6. Clearwater, Florida
  7. DeLand, Florida
  8. Miami, Florida
  9. Orlando, Florida
  10. Atlanta, Georgia
  11. Overland Park, Kansas
  12. Overland Park, Kansas
  13. Overland Park, Kansas
  14. Kansas City, Missouri
  15. Kansas City, Missouri
  16. Saint Louis, Missouri
  17. Raleigh, North Carolina
  18. Raleigh, North Carolina
  19. Oklahoma City, Oklahoma
  20. Oklahoma City, Oklahoma
  21. Oklahoma City, Oklahoma
  22. Oklahoma City, Oklahoma
  23. Duncansville, Pennsylvania
  24. Greer, South Carolina
  25. Kingsport, Tennessee
  26. Houston, Texas
  27. Tomball, Texas
  28. Orem, Utah
  29. Richmond, Virginia
  30. Kelowna, British Columbia
  31. Chicoutimi, Quebec
  32. Laval, Quebec
  33. Montreal, Quebec
  34. Sherbrooke, Quebec
  35. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaA Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
NCT01342211
  1. Tustin, California
  2. Walnut Creek, California
  3. Clearwater, Florida
  4. DeLand, Florida
  5. Doral, Florida
  6. Jacksonville, Florida
  7. Miami, Florida
  8. Woodstock, Georgia
  9. Woodstock, Georgia
  10. Overland Park, Kansas
  11. Wichita, Kansas
  12. Louisville, Kentucky
  13. Madisonville, Kentucky
  14. Auburn, Maine
  15. North Dartmouth, Massachusetts
  16. Kansas City, Missouri
  17. Kansas City, Missouri
  18. Kansas City, Missouri
  19. Saint Louis, Missouri
  20. Albuquerque, New Mexico
  21. Raleigh, North Carolina
  22. Salisbury, North Carolina
  23. Oklahoma City, Oklahoma
  24. Oklahoma City, Oklahoma
  25. Oklahoma City, Oklahoma
  26. Oklahoma City, Oklahoma
  27. Duncansville, Pennsylvania
  28. Philadelphia, Pennsylvania
  29. Philadelphia, Pennsylvania
  30. Spartanburg, South Carolina
  31. Knoxville, Tennessee
  32. Knoxville, Tennessee
  33. Houston, Texas
  34. San Antonio, Texas
  35. San Antonio, Texas
  36. San Antonio, Texas
  37. Norfolk, Virginia
  38. Richmond, Virginia
  39. Kelowna, British Columbia
  40. Chicoutimi, Quebec
  41. Laval, Quebec
  42. Montreal, Quebec
  43. Sherbrooke, Quebec
  44. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaPharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
NCT01163851
  1. Peoria, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Overland Park, Kansas
  5. Overland Park, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaMultiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
NCT01163838
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Hypercholesterolemia
  • Dyslipidemia
Intervention  ICMJE
  • Biological: 4 mg/kg
    RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
    Other Name: PF-04950615 (RN316)
  • Biological: 0.5 mg/kg
    RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
    Other Name: PF-04950615 (RN316)
Study Arms  ICMJE Experimental: PF-04950615 (RN316)
Interventions:
  • Biological: 4 mg/kg
  • Biological: 0.5 mg/kg
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
 (submitted: June 17, 2011)		25
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)		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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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