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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01478399

Run by

PhaseBio Pharmaceuticals Inc.

People needed

16

Starts

2011-12-01

Expected to finish

2012-10-01

Last updated by the study team

2013-04-15

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Prism Research — Saint Paul, Minnesota, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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