Study of the Pharmacokinetics of ASP1941 and the Effect o... | NCT01678287

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	Arm 1 Non elderly receiving ASP1941 Arm 3 Elderly receiving ASP1941

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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%)

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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