JPRN-jRCT1080221208
Recruiting
Phase 1
Y139603 Bioequivalence Study Comparing Atomoxetine Oral Solution and Capsule Formulation in Healthy Adult Male Japanese Subjects
ConditionsAttention Deficit Hyperactivity Disorder
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Eli Lilly Japan K.K.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Are healthy Japanese, as determined by medical history and physical examination.
- •\- Have a body mass index (BMI) of greater than or equal to 17\.6 and less than or equal to 26\.4 kg/m2 at screening.
- •\- CYP2D6 genotype is categorized as EM from the result of screening test. EM includes Intermediate Metabolizer (IM) and Ultrarapid Metabolizer (UM).
- •\- Have clinical laboratory test results within normal reference range for the population and investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- •\- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- •\- Have given written informed consent approved by Lilly and the ethical review board governing the site before any trial activities.
Exclusion Criteria
- •\- Are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •\- Persons who are employed by the sponsor (that is, employees, temporary contract workers, or designees responsible for conducting the study).
- •\- Are currently enrolled in, or discontinued within the last 4 months from, a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •\- Have known allergies to atomoxetine (LY139603\) or related compounds.
- •\- Are persons who have ever used atomoxetine, or previously participated in this study or any other study investigating atomoxetine and received the study drug.
- •\- An abnormality in the 12\-lead ECG that in the opinion of the investigator increases the risk of participating in the study, such as a corrected QTc interval \>450 msec.
- •\- Subjects with a current or past history of clinically significant elevated blood pressure (Supine systolic blood pressure greater than or equal to 140 mmHg or Supine diastolic blood pressure greater than or equal to 90 mmHg)
- •\- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or of interfering with the interpretation of data.
- •\- Regularly use known drugs of abuse, or show positive findings on urinary drug screening.
- •\- Have a positive result for Human Immunodeficiency Virus (HIV) test, or show evidence of possible infection.
Outcomes
Primary Outcomes
Not specified
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