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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:December 2011
End Date:July 2012

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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


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.


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 (± 10 years), weight (± 10 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.
We found this trial at
2
sites
1000 Westgate Drive
St Paul, Minnesota 55114
651-641-2900
622
mi
from 43215
St Paul, MN
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Knoxville, Tennessee 37920
280
mi
from 43215
Knoxville, TN
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