A Study of the Effect of ASP1941 on Cardiac Repolarization in Healthy Subjects

NCT01232413 | Completed Phase 1

• 1 other identifier: 1941-CL-0058
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effect of repeat oral dosing of ASP1941 on electrocardiogram (ECG) measurements.

Conditions

Healthy Subjects; Cardiac Repolarization

Keywords

Thorough QT (TQT); ASP1941

Outcome Measures

Primary Outcomes (1)

• QTcF evaluated through electrocardiogram analysis (ECG)

  QTcF is a QT interval corrected for heart rate (Fridericia's formula)

  Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

Secondary Outcomes (3)

• Evaluation of Electrocardiogram (ECG)

  Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

• QTcI evaluated through electrocardiogram analysis

  Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

• QTcB evaluated through electrocardiogram analysis (ECG)

  Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4)

Study Arms (4)

Treatment A

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Treatment B

EXPERIMENTAL

ASP1941 low dose

Drug: ASP1941

Treatment C

EXPERIMENTAL

ASP1941 high dose

Drug: ASP1941

Treatment D

ACTIVE COMPARATOR

Moxifloxacin

Drug: Moxifloxacin

Interventions

Placebo DRUG

Oral

Treatment A

ASP1941 DRUG

Oral

Treatment B; Treatment C

Moxifloxacin DRUG

Oral

Also known as: Avelox

Treatment D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject weighs at least 45 kg, and has a body mass index (BMI) of 18 to 32 kg/m2
• If female, subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control, and not pregnant or lactating
• The male or female subject agrees to practice highly effective birth control until 30 days post last study drug dose
• The subject is highly likely to comply with the protocol-defined procedures and complete the study

You may not qualify if:

• The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death due to cardiac causes at a young age of a close relative)
• The subject anticipates an inability to abstain from alcohol, or caffeine use, or from grapefruit and grapefruit juice from 72 hours prior to dosing and throughout the duration of the study
• The subject has used tobacco-containing products and nicotine or nicotine-containing products within past six months
• The subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance during specified times (e.g., prior to and in ECG extraction windows) of music, TV, movies, games and activities that may cause excitement, emotional tension or arousal
• The subject is unwilling to comply with study rules, including attempting to void at specified times (e.g., prior to ECG extraction windows), remaining quiet, awake, undistracted, motionless and supine during specified times, and avoiding vigorous exercise as directed
• The subject is unable to tolerate study-specific diet
• The subject has a history or evidence of any clinically significant cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
• The subject has a history of clinically significant allergic conditions or anaphylactic reactions
• The subject has any condition possibly affecting drug absorption
• The subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years
• The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous)infection within 1 week prior to clinic check in for any treatment period
• The subject is known positive for human immunodeficiency virus (HIV) antibody
• The subject has a positive test for hepatitis C antibody, or positive for hepatitis B antigen (HBsAg)
• The subject has used prescription or non-prescription drugs within 14 days or 5-half lives (whichever is longer) or complementary and alternative medicines (CAM) within 28 days prior to Day -2 of Period 1 (excluding oral contraceptives, hormone replacement therapy \[HRT\], and acetaminophen)
• The subject has received an experimental agent within 30 days or 10 half-lives, whichever is longer, prior to study drug administration

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

West Bend, Wisconsin, 53095, United States

Location

Related Publications (1)

• Zhang W, Smulders R, Abeyratne A, Dietz A, Krauwinkel W, Kadokura T, Keirns J. Ipragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study. Clin Ther. 2013 Aug;35(8):1150-1161.e3. doi: 10.1016/j.clinthera.2013.06.009. Epub 2013 Aug 2.

  PMID: 23910665 DERIVED

MeSH Terms

Interventions

ipragliflozin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 2, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 28, 2011

Record last verified: 2011-02

Locations

US (1)