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

• Sponsor: Astellas Pharma Global Development, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01678287
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 32.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers; Pharmacokinetics of ASP1941	Drug: ASP1941; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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)
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Number of adverse events (AEs) [Through Day 29]

2. Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations [Through Day 29]

3. Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, 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]

   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)

4. Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, 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]

   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)

5. Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR [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]

   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

1. 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]

2. Pharmacodynamic profile of urine glucose: Aelast and Aetau [Day 1 and Day 18]

3. Rate of glucose excretion per sampling interval [Day 1 and Day 18]

4. Rate of glucose excretion over 24 hours [Day 1 and Day 18]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astellas Pharma Global Development, Inc.
• ClinicalTrials.gov Identifier: NCT01678287
• Other Study ID Numbers: 1941-CL-0052
• First Posted: Sep 5, 2012
• Last Update Posted: Sep 5, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Astellas Pharma Global Development, Inc.: ASP1941
• Additional relevant MeSH terms: Ipragliflozin

Study Results

No Results Posted as of Sep 5, 2012