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Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.

- Healthy subjects must have fasting LDL-C >/= 70 to = 190 mg/dL at two qualifying
visits.

- Hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45
days before dosing and fasting LDL-C must be >/= 70 mg/dL.

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

- Use of prescription or non-prescription drugs within 7 days or 5 half-lives
(whichever) is longer prior to the first dose of study medication. For
hypercholesterolemic subjects the use of statin class medication is allowed.

- Prior exposure to bococizumab (also known as PF-04950615 or RN316) or other
investigational PCSK9 inhibitors.

- Treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is
longer) before dosing.

NCT02667223
Pfizer
Terminated
Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

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Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase
A Phase 1, Open Label, Randomized, Single Dose, Dose Escalation Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab (pf 04950615) Alone And In Co Mixture With Recombinant Human Hyaluronidase (rhuph20, Pf 06744547) In Healthy And Hypercholesterolemic Adult Subjects
This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Healthy
  • Hypercholesterolemia
  • Biological: Cohort 1: bococizumab 150 mg + rHuPH20
    bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 2: bococizumab 300 mg
    bococizumab 300 mg administered SC to healthy volunteers
  • Biological: Cohort 3: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 5: bococizumab 450 mg + rHuPH20
    bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 4: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin
  • Experimental: Cohort 1: bococizumab 150 mg + rHuPH20
    bococizumab 150 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 1: bococizumab 150 mg + rHuPH20
  • Active Comparator: Cohort 2: bococizumab 300 mg
    bococizumab 300 mg administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 2: bococizumab 300 mg
  • Experimental: Cohort 3: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 3: bococizumab 300 mg + rHuPH20
  • Experimental: Cohort 5: bococizumab 450 mg + rHUPH20
    bococizumab 450 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 5: bococizumab 450 mg + rHuPH20
  • Experimental: Cohort 4: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to subjects with hypercholesterolemia receiving a statin
    Intervention: Biological: Cohort 4: bococizumab 300 mg + rHuPH20
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.
  • Healthy subjects must have fasting LDL-C >/= 70 to
  • Hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45 days before dosing and fasting LDL-C must be >/= 70 mg/dL.

Exclusion Criteria:

  • Use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever) is longer prior to the first dose of study medication. For hypercholesterolemic subjects the use of statin class medication is allowed.
  • Prior exposure to bococizumab (also known as PF-04950615 or RN316) or other investigational PCSK9 inhibitors.
  • Treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is longer) before dosing.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02667223
B1481051
2015-003568-36 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Halozyme Therapeutics
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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