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

NCT01478399 | Completed Phase 1 DMC

• 1 other identifier: PB1023-PT-CL-0003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  The PK analysis population will consist of subjects that complete the study and have sufficient data for PK analysis. The following parameters will be evaluated: t1/2, AUC(0-inf), Tmax, Cmax, elimination rate constant, CL/F, Vz/F.

  Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28

Secondary Outcomes (1)

• Safety/Tolerability

  Screening to Final Visit (Approximately 6 weeks)

Study Arms (2)

Impaired Renal Function

EXPERIMENTAL

Subjects have impaired renal function matched to subjects with normal renal function by age and weight.

Drug: PB1023 Injection

Normal Renal Function

EXPERIMENTAL

Subjects have normal renal function matched to subjects with impaired renal function by age and weight.

Drug: PB1023 Injection

Interventions

PB1023 Injection DRUG

90 mg Dose

Impaired Renal Function; Normal Renal Function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• PhaseBio Pharmaceuticals Inc.: lead

Study Sites (2)

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel K. Ries, MD

  Prism Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

US (2)