Clinical trial NCT01478399: Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: PhaseBio Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Secondary outcomes:
measure: Safety/Tolerability
timeFrame: Screening to Final Visit (Approximately 6 weeks)
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
Study officials:
affiliation: Prism Research Inc.
name: Daniel K. Ries, MD
role: PRINCIPAL_INVESTIGATOR
References: