Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGPB1023 Injection
90 mg Dose
Sponsors
PhaseBio Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety/Tolerability | Screening to Final Visit (Approximately 6 weeks) | Safety and tolerability will be evaluated by analyses of the incidence of adverse events. Vital signs, ECGs and safety laboratory parameters will be presented descriptively. |
Countries
United States
Outcome results
None listed