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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478399
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : April 15, 2013
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: PB1023 Injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 ]
    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 :
  1. Safety/Tolerability [ Time Frame: Screening to Final Visit (Approximately 6 weeks) ]
    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.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01478399

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.
Principal Investigator: Daniel K. Ries, MD Prism Research Inc.

Responsible Party: PhaseBio Pharmaceuticals Inc. Identifier: NCT01478399     History of Changes
Other Study ID Numbers: PB1023-PT-CL-0003
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

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