Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01835730
First received: March 28, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: PE0139 Injection
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Multicenter, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by PhaseBio Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change in Vital Signs from baseline (Day 0 Pre-dose) [ Time Frame: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the change from baseline in vital signs.

  • Change in ECGs from baseline (Day -1) [ Time Frame: ECG Days 2 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.

  • Change in Safety Labs from baseline (Pre-dose) [ Time Frame: Safety Labs Days 0, 7 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by analyses of the safety laboratory parameters.

  • Incidence and severity of immunogenicity [ Time Frame: Immunogenicity Days 0, 7, 14 and 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the incidence and severity of immunogenicity.

  • Incidence and severity of adverse events including hypoglycemia [ Time Frame: As reported between Days -10 to 28 ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.


Secondary Outcome Measures:
  • Pharmacokinetic Profile [ Time Frame: Day 0, 1, 2, 3, 4, 5, 6, and 7 ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters include: Area under the concentration curve from time 0 to infinity (AUC(0-inf)), Area under the concentration curve to the final sample with a concentration greater than or equal to Limit of Quantitation (LOQ) (AUC(0-t)), Time to maximum concentration (Tmax), Maximum serum concentration (Cmax), Elimination rate constant (Lambda-z), Elimination half-life (t1/2), Clearance uncorrected for bioavailability (CL/F), Distribution uncorrected for bioavailability (Vz/F)

  • Pharmacodynamic Response [ Time Frame: FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7 ] [ Designated as safety issue: No ]
    To assess the pharmacodynamic response (time action profile) of various single doses of PE0139. Assessments include Fasting plasma glucose (FPG), 4-point serial glucose monitoring and glucose assessed by continuous glucose monitoring (CGM).


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PE0139 Injection
Single subcutaneous injection of PE0139, 40 mg/mL
Drug: PE0139 Injection
Placebo Comparator: Placebo
Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to sign a written informed consent and follow all study-related procedures;
  • Male and female subjects at least 18 years of age;
  • Male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their dose of study drug;
  • Body mass index ≤45 kg/m2;
  • Diagnosed with T2DM and who is currently taking a stable daily dose of a basal insulin (Lantus) plus at least one oral antihyperglycemic agent at a stable dose for 3 months prior to screening.

Exclusion Criteria:

  • Currently taking or have taken within 3 months prior to screening an approved or investigational GLP-1 analogue/agonist (e.g., Victoza®) or pramlintide;
  • Currently taking or have routinely taken, within 3 months prior to screening , a short-acting insulin;
  • Currently taking or have taken, within 3 months prior to screening, a long acting insulin other than Lantus®;
  • Known allergy to, or serious adverse effect caused by an approved, or investigational insulin product or any of its components;
  • Currently taking any of the following medications: thiazide or furosemide diuretics, beta-blockers, estrogens or other hormonal replacement therapy, or other chronic medications with known adverse effects on glucose tolerance levels unless the subject has been on stable doses of such agents for at least 2 months prior to screening and have no planned changes during the study period;
  • History of recurrent severe hypoglycemia (more than 2 episodes within the last 6 months prior to randomization or hypoglycemic unawareness;
  • Malignant disease defined as 1) any history of malignant melanoma or breast cancer and/or 2) history of other types of cancer within the last 5 years prior to screening;
  • Unstable cardiovascular disease defined as one or more of the following: History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; History of or currently have New York Heart Association Class III-IV heart failure prior to screening; Uncontrolled/sustained hypertension; History or evidence of long QT syndrome or mean triplicate 12-lead electrocardiogram demonstrating QT interval;
  • Clinically significant renal and/or hepatic dysfunction;
  • Absolute requirement for corticosteroids or have received systemic steroids within 3 months prior to Randomization (V5, Day -1). Note: Use of inhaled or topical corticosteroids will be permitted;
  • Pregnant or lactating female subjects;
  • Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to screening;
  • Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at V1;
  • Participating in any other study and have received any other investigational medication or device within 30 days prior to Visit 1.
  • Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835730

Locations
United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, Florida
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
United States, Washington
Rainier Clinical Research
Renton, Washington, United States, 98057
Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
Investigators
Principal Investigator: Ronald Brazg, MD Rainier Clinical Research
  More Information

No publications provided

Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01835730     History of Changes
Other Study ID Numbers: PE0139-PT-CL-0001
Study First Received: March 28, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014