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

NCT01678287 | Completed Phase 1

• 1 other identifier: 1941-CL-0052
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Pharmacokinetics of ASP1941

Keywords

ASP1941

Outcome Measures

Primary Outcomes (5)

• Number of adverse events (AEs)

  Through Day 29

• Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations

  Through Day 29

• Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR

  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)

  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

• Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR

  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)

  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

• Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR

  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%)

  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

Secondary Outcomes (4)

• Pharmacodynamic profile of blood glucose: Cmax and AUCtau

  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

• Pharmacodynamic profile of urine glucose: Aelast and Aetau

  Day 1 and Day 18

• Rate of glucose excretion per sampling interval

  Day 1 and Day 18

• Rate of glucose excretion over 24 hours

  Day 1 and Day 18

Study Arms (4)

Arm 1 Non elderly receiving ASP1941

EXPERIMENTAL

healthy subjects age 18 to 45 years receiving ASP1941

Drug: ASP1941

Arm 2 Non elderly receiving placebo

EXPERIMENTAL

healthy subjects age 18 to 45 years receiving placebo

Drug: Placebo

Arm 3 Elderly receiving ASP1941

EXPERIMENTAL

healthy subjects age ≥ 65 years receiving ASP1941

Drug: ASP1941

Arm 4 Elderly receiving placebo

EXPERIMENTAL

healthy subjects age ≥ 65 years receiving placebo

Drug: Placebo

Interventions

ASP1941 DRUG

oral

Arm 1 Non elderly receiving ASP1941; Arm 3 Elderly receiving ASP1941

Placebo DRUG

oral

Arm 2 Non elderly receiving placebo; Arm 4 Elderly receiving placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (1)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

MeSH Terms

Interventions

ipragliflozin

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: September 5, 2012
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 5, 2012

Record last verified: 2012-08

Locations

US (1)