Trial record 12 of 359 for:    Open Studies | "Diabetes Mellitus, Type 1"

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

This study is not yet open for participant recruitment.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02038764
First received: January 15, 2014
Last updated: April 7, 2014
Last verified: April 2014
  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: 40
Study Start Date: April 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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
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, Georgia
Pfizer Investigational Site Not yet recruiting
Atlanta, Georgia, United States, 30318
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: April 7, 2014
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014