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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01232413
First received: October 27, 2010
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Cardiac Repolarization
Drug: Placebo
Drug: ASP1941
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Repeat Oral Doses of ASP1941 on Cardiac Repolarization in Healthy Male and Female Adult Subjects

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • QTcF evaluated through electrocardiogram analysis (ECG) [ Time Frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) ] [ Designated as safety issue: No ]
    QTcF is a QT interval corrected for heart rate (Fridericia's formula)


Secondary Outcome Measures:
  • Evaluation of Electrocardiogram (ECG) [ Time Frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) ] [ Designated as safety issue: No ]
  • QTcI evaluated through electrocardiogram analysis [ Time Frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) ] [ Designated as safety issue: No ]
    QTcI is a QT interval corrected for individual heart rate

  • QTcB evaluated through electrocardiogram analysis (ECG) [ Time Frame: Days -1, 1 and 7 (period 1) and Days 1 and 7 (period 2-4) ] [ Designated as safety issue: No ]
    QTcB is a QT interval corrected for heart rate (Bazett's formula)


Enrollment: 88
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A
Placebo
Drug: Placebo
Oral
Experimental: Treatment B
ASP1941 low dose
Drug: ASP1941
Oral
Experimental: Treatment C
ASP1941 high dose
Drug: ASP1941
Oral
Active Comparator: Treatment D
Moxifloxacin
Drug: Moxifloxacin
Oral
Other Name: Avelox

Detailed Description:

Subjects will be randomized in four treatment sequences of twenty subjects each. Subjects in each treatment sequence will participate in a total of four treatment periods (A, B, C, and D) separated by washout periods of at least 7 days from completion of the prior period (Day 8) through clinical check-in (Day -1) of the next study period.

For Period 1, subjects will be admitted to the clinical research unit on Day -2. For each subsequent study period, subjects will be admitted to the clinical research unit on Day -1. Subjects will be discharged from the unit after completing procedures on Day 8 of each period. Subjects will receive a follow-up telephone call 7-10 days after their last clinic day (Period 4\Early Discontinuation [ED]).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • The subject is participating in another clinical trial or has participated in another dose group of the current trial
  • The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232413

Locations
United States, Wisconsin
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01232413     History of Changes
Other Study ID Numbers: 1941-CL-0058
Study First Received: October 27, 2010
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Thorough QT (TQT)
ASP1941

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014