Clinical trial NCT01678287: Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pharmacokinetics of ASP1941
Keywords: ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: Through Day 29
measure: Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations
timeFrame: Through Day 29
measure: Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR
timeFrame: 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
measure: Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR
timeFrame: 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
measure: Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR
timeFrame: 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:
measure: Pharmacodynamic profile of blood glucose: Cmax and AUCtau
timeFrame: 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
measure: Pharmacodynamic profile of urine glucose: Aelast and Aetau
timeFrame: Day 1 and Day 18
measure: Rate of glucose excretion per sampling interval
timeFrame: Day 1 and Day 18
measure: Rate of glucose excretion over 24 hours
timeFrame: Day 1 and Day 18
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References: