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Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01478399
First received: November 21, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

Primary objective:

To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.

Secondary objectives:

To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: PB1023 Injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Open-Label Pharmacokinetic, Safety and Tolerability Study of a Single Subcutaneous Dose of Glymera (PB1023) Injection in Subjects With Normal Renal Function and Subjects With Impaired Renal Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PhaseBio Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 ] [ Designated as safety issue: No ]
    The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F.


Secondary Outcome Measures:
  • Safety/Tolerability [ Time Frame: Screening to Final Visit (Approximately 6 weeks) ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be evaluated by analyses of the incidence of adverse events. Vital signs, ECGs and safety laboratory parameters will be presented descriptively.


Enrollment: 16
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Impaired Renal Function
Subjects have impaired renal function matched to subjects with normal renal function by age and weight.
 Drug: PB1023 Injection
90 mg Dose
Experimental: Normal Renal Function
Subjects have normal renal function matched to subjects with impaired renal function by age and weight.
 Drug: PB1023 Injection
90 mg Dose

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females age 18 - 79 years of age inclusive.
  • BMI 19 - 40 kg/m2.
  • Renally Impaired Subjects: In otherwise stable health except for Renal Disease.
  • Healthy volunteers must have/be: eGFR as calculated by MDRD of ≥ 80 mL/min, and Matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible BMI, race and gender.
  • Subjects with renal impairment must have 2 separate eGFR that are within 20% of each other and clinically stable for a minimum of 6 months.
  • No clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the Investigator.

Exclusion Criteria:

  • Currently taking or have taken a GLP -1 agent (e.g., Byetta®, Victoza®) within the past year.
  • Subjects who have previously received PB1023.
  • Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
  • Serious Infection within 60 days of admission.
  • Donation or loss of greater than 400 mL of blood 56 days prior to enrollment.
  • Unstable cardiovascular disease defined as per protocol.
  • Clinically significant hepatic dysfunction defined as per protocol.
  • Female subjects who are pregnant, trying to become pregnant or lactating.
  • Known history of or active alcohol or drug abuse within 12 months prior to Screening or positive alcohol and/or drug screen.
  • Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.
  • Participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478399

Locations
United States, Minnesota
Prism Research
Saint Paul, Minnesota, United States, 55114
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
Investigators
Principal Investigator: Daniel K. Ries, MD Prism Research Inc.
  More Information

No publications provided

Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01478399     History of Changes
Other Study ID Numbers: PB1023-PT-CL-0003
Study First Received: November 21, 2011
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013