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A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02038764
First received: January 15, 2014
Last updated: February 12, 2015
Last verified: February 2015
  Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Placebo
Biological: PF-06342674 Dose A
Biological: PF-06342674 Dose B
Biological: PF-06342674 Dose C
Biological: PF-06342674 Dose D
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Adults With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of dose limiting or intolerable treatment related AEs [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent AEs [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Incidence and severity of hypoglycemic events [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal laboratory findings [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug antibodies [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Severity of treatment emergent AEs [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Causal relationship of treatment emergent AEs [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]
  • ECG parameters [ Time Frame: 127 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Apparent Oral Clearance (CL/F) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Volume of Distribution at Steady State (Vss) [ Time Frame: 127 days ] [ Designated as safety issue: No ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  • Accumulation ratio (R) [ Time Frame: 127 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: PF-06342674 Biological: PF-06342674 Dose A
Multiple SC Doses
Biological: PF-06342674 Dose B
Multiple SC Doses
Biological: PF-06342674 Dose C
Multiple SC Doses
Biological: PF-06342674 Dose D
Multiple SC Doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men age 18 and older.
  • Diagnosis of type 1 diabetes within 2 years of randomization.
  • Peak stimulated C-peptide levels ≥ 0.15 ng/mL.

Exclusion Criteria:

  • Anticipated ongoing use of diabetes medications other than insulin.
  • Evidence or history of diabetic complications with significant end-organ damage.
  • Episode of severe hypoglycemia within 60 days of randomization.
  • Multiple hospitalizations for diabetic ketoacidosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038764

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
University of California, San Francisco, Gateway Medical Building Recruiting
San Francisco, California, United States, 94143
United States, Colorado
Barbara Davis Center for Childhood Diabetes Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Minnesota
University Of Minnesota Fairview Pharmacy Services Recruiting
Minneapolis, Minnesota, United States, 55455
University Of Minnesota Medical School Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02038764     History of Changes
Other Study ID Numbers: B4351003
Study First Received: January 15, 2014
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
RN168
Adults
Type 1 Diabetes
T1D

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015