Status:
COMPLETED
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Lead Sponsor:
PhaseBio Pharmaceuticals Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01478399
Start Date
December 1 2011
End Date
October 1 2012
Last Update
April 15 2013
Active Locations (2)
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1
Prism Research
Saint Paul, Minnesota, United States, 55114
2
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920