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

Healthy Volunteers Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678287
• Other study ID #: 1941-CL-0052
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2012
• Last updated: August 30, 2012
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral
• Placebo
oral

Locations

Country	Name	City	State
United States	Comprehensive Phase One	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events (AEs)		Through Day 29	No
Primary	Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations		Through Day 29	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Pharmacodynamic profile of urine glucose: Aelast and Aetau		Day 1 and Day 18	No
Secondary	Rate of glucose excretion per sampling interval		Day 1 and Day 18	No
Secondary	Rate of glucose excretion over 24 hours		Day 1 and Day 18	No