Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01678287
First received: August 27, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy adult male and female subjects.


Condition Intervention Phase
Healthy Volunteers
Pharmacokinetics of ASP1941
Drug: ASP1941
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Dosing of ASP1941 and to Explore the Effect of ASP1941 on Glucose Levels in Healthy Adult Subjects (18 to 45 Years and ≥ 65 Years)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Number of adverse events (AEs) [ Time Frame: Through Day 29 ] [ Designated as safety issue: No ]
  • Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations [ Time Frame: Through Day 29 ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR [ Time Frame: Days 1 and 18 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose ] [ Designated as safety issue: No ]
    Area under the curve over the time interval between consecutive dosing (AUCtau),Apparent total body clearance after extravascular dosing (CL/F), Maximum observed concentration (Cmax), Time to reach Cmax (Tmax), Terminal elimination half-life (t1/2), Apparent volume of distribution during the terminal phase after single or repeated extravascular dosing (Vz/F), Peak Trough Ratio (PTR)

  • Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR [ Time Frame: Day 1 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose ] [ Designated as safety issue: No ]
    Cumulative amount of drug excreted into urine up to the ending time of the last collection period (Ae), Fraction of the drug excreted in urine (Ae) in % up to the ending time of last collection period (Ae%), Cumulative amount of drug or glucose excreted into urine up to the collection time of the last measurable amount (Aelast),Fraction of drug excreted into urine (Ae) in % up to the collection time of the last measurable concentration (Aelast% ), Fraction of glucose excreted into urine up to 24 hrs (Ae24), Renal clearance (CLR)

  • Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR [ Time Frame: Day 18 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose ] [ Designated as safety issue: No ]
    Cumulative amount of drug or glucose excreted into urine over the time interval between consecutive dosing (Aetau ), Fraction of drug or glucose excreted into urine (Aetau) in % over the time interval between consecutive dosing (Aetau%)


Secondary Outcome Measures:
  • Pharmacodynamic profile of blood glucose: Cmax and AUCtau [ Time Frame: Day -1 at -24, -23.75, -23.5, -23, -22.5, -22, -21, -20, -18, -16, -12, -8 and 0 (predose) hours prior to dose on Day 1 and on Day 18 predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic profile of urine glucose: Aelast and Aetau [ Time Frame: Day 1 and Day 18 ] [ Designated as safety issue: No ]
  • Rate of glucose excretion per sampling interval [ Time Frame: Day 1 and Day 18 ] [ Designated as safety issue: No ]
  • Rate of glucose excretion over 24 hours [ Time Frame: Day 1 and Day 18 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Non elderly receiving ASP1941
healthy subjects age 18 to 45 years receiving ASP1941
Drug: ASP1941
oral
Experimental: Arm 2 Non elderly receiving placebo
healthy subjects age 18 to 45 years receiving placebo
Drug: Placebo
oral
Experimental: Arm 3 Elderly receiving ASP1941
healthy subjects age ≥ 65 years receiving ASP1941
Drug: ASP1941
oral
Experimental: Arm 4 Elderly receiving placebo
healthy subjects age ≥ 65 years receiving placebo
Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, healthy non-elderly (age 18-45 years, inclusive) or healthy elderly (age 65 or over)
  • If female, subject is not pregnant or nursing, and uses medically acceptable contraceptive method to prevent pregnancy from screening until study discharge
  • Body weigh between 60 and 100kg and body Mass Index between 20 and 30kg/m2, inclusive
  • Negative urine screen for drugs of abuse, including alcohol and cotinine

Exclusion Criteria:

  • History of type 1 or type 2 diabetes
  • Fasting plasma glucose level higher than 6.4mmol/L or hemoglobin A1c level higher than 6.2%
  • Presence of renal glucosuria and/or proteinuria
  • Clinically significant history of asthma, eczema, and or any other allergic condition.
  • Clinically significant history of upper gastrointestinal symptoms within the 4 weeks prior to admission to the clinical unit.
  • History of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study.
  • History of multiple drug allergies or a known allergy or suspected hypersensitivity to the study drug or any chemically related derivatives of the study drug or any components of the formulation
  • Has hepatitis or a positive result to serology test for hepatitis A antibody Immunoglobulin M, hepatitis B surface antigen or hepatitis C virus at screening
  • Known to be positive for human immunodeficiency virus antibodies.
  • Donated one unit (450 mL) or more of blood or plasma within 60 days prior to the first dose of study medication.
  • Has a history of consuming more than an average of 2 ounces of alcohol-containing products per day or a history of alcoholism or drug/chemical abuse within the last 3 years.
  • Use of any tobacco or nicotine-containing products within 120 days prior to the first dose of study medication.
  • Taken any prescribed systemic or topical medication within 21 days prior to the first dose of study medication with the exception of contraceptives to prevent pregnancy.
  • Taken any systemic or topical over-the counter medication, complementary or alternative medications, e.g., vitamins, herbal, or nutritional supplements, with the exception of acetaminophen, within 10 days prior to the first dose of study medication.
  • Taken an investigational drug within 30 days of the first dose of study medication
  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: NCT01678287

Locations
United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01678287     History of Changes
Other Study ID Numbers: 1941-CL-0052
Study First Received: August 27, 2012
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP1941

ClinicalTrials.gov processed this record on September 30, 2014