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 |
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.
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