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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01478399
First received: November 21, 2011
Last updated: April 12, 2013
Last verified: April 2013

November 21, 2011
April 12, 2013
December 2011
October 2012   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 ] [ Designated as safety issue: No ]
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.
Pharmacokinetics [ Time Frame: Pre-Dose, 1, 4, 8 and 12 hours post-dose, Day 1, 2, 3, 5, 7, 10, 14, 21 and 28 ] [ Designated as safety issue: No ]
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 contstant, CL/F, Vz/F.
Complete list of historical versions of study NCT01478399 on ClinicalTrials.gov Archive Site
Safety/Tolerability [ Time Frame: Screening to Final Visit (Approximately 6 weeks) ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: PB1023 Injection
90 mg Dose
  • Experimental: Impaired Renal Function
    Subjects have impaired renal function matched to subjects with normal renal function by age and weight.
    Intervention: Drug: PB1023 Injection
  • Experimental: Normal Renal Function
    Subjects have normal renal function matched to subjects with impaired renal function by age and weight.
    Intervention: Drug: PB1023 Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01478399
PB1023-PT-CL-0003
Yes
PhaseBio Pharmaceuticals Inc.
PhaseBio Pharmaceuticals Inc.
Not Provided
Principal Investigator: Daniel K. Ries, MD Prism Research Inc.
PhaseBio Pharmaceuticals Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP