A Bioequivalence (BE) Study in Healthy Subjects

NCT01177943 | Completed Phase 1 Results

• 2 other identifiers: 13554B4Z-JE-LYEO
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter \[mg/mL\]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax)

  The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.

  Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]

  The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.

  Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose

Study Arms (2)

Atomoxetine Oral Solution

EXPERIMENTAL

Drug: Atomoxetine

Atomoxetine Capsule Formulation

ACTIVE COMPARATOR

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

Administered orally, once.

Also known as: LY139603, Strattera

Atomoxetine Capsule Formulation; Atomoxetine Oral Solution

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are healthy Japanese males, 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
• Cytochrome P450 2D6 (CYP2D6) genotype is categorized as extensive metabolizers (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

You may not qualify if:

• 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 QT (QTc) interval \>450 milliseconds (msec).
• Subjects with a current or past history of clinically significant elevated blood pressure (Supine systolic blood pressure greater than or equal to 140 millimeters of mercury \[mmHg\] 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.
• Have a positive result for hepatitis B antigen test, or show evidence of possible infection.
• Have a positive result for hepatitis C antibody test, or show evidence of possible infection.
• Have a positive result for syphilis test, or show evidence of possible infection.
• Use or intend to use over-the-counter or prescription medication 7 and 14 days, respectively prior to dosing.
• Blood donation of more than 200 mL of blood and component blood donation within one month prior to dosing, or those who have donated more than 400 mL of blood within 3 month prior to dosing, or history of blood donation of more than 950 mL within the last 12 months.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, 810-0064, Japan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 27, 2011
• Results First Posted: October 27, 2011

Record last verified: 2011-09

Locations

JP (1)