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

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ClinicalTrials.gov Identifier: NCT02038764
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Masking: Double (Participant, 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
Study Start Date : June 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of dose limiting or intolerable treatment related AEs [ Time Frame: 127 days ]
  2. Incidence of treatment emergent AEs [ Time Frame: 127 days ]
  3. Incidence and severity of hypoglycemic events [ Time Frame: 127 days ]
  4. Incidence of abnormal laboratory findings [ Time Frame: 127 days ]
  5. Vital signs [ Time Frame: 127 days ]
  6. Incidence of anti-drug antibodies [ Time Frame: 127 days ]
  7. Severity of treatment emergent AEs [ Time Frame: 127 days ]
  8. Causal relationship of treatment emergent AEs [ Time Frame: 127 days ]
  9. Blood pressure [ Time Frame: 127 days ]
  10. ECG parameters [ Time Frame: 127 days ]

Secondary Outcome Measures :
  1. Area under the Concentration-Time Curve (AUC) [ Time Frame: 127 days ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  2. Apparent Oral Clearance (CL/F) [ Time Frame: 127 days ]
    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.

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 127 days ]
  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 127 days ]
  5. Plasma Decay Half-Life (t1/2) [ Time Frame: 127 days ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  6. Volume of Distribution at Steady State (Vss) [ Time Frame: 127 days ]
    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.

  7. Accumulation ratio (R) [ Time Frame: 127 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038764


Locations
United States, California
VA San Diego Healthcare System (Drug Shipment)
San Diego, California, United States, 92161
Veterans Administration San Diego Healthcare System
San Diego, California, United States, 92161
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Yale New Haven Hospital - Investigational Drug Services
New Haven, Connecticut, United States, 06511
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Illinois
Duchossois Center for Advanced Medicine
Chicago, Illinois, United States, 60637
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University of Chicago Clinical Resource Center
Chicago, Illinois, United States, 60637
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
United States, Minnesota
University Of Minnesota Fairview Pharmacy Services
Minneapolis, Minnesota, United States, 55454
University Of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Barnes- Jewish HOSP Att: Kathryn Vehe
St. Louis, Missouri, United States, 63110
Washington University - Center for Advanced Medicine
St. Louis, Missouri, United States, 63110
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Duke University Health Systems (DUHS) Investigational Drug Services
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02038764     History of Changes
Other Study ID Numbers: B4351003
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

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

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