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Attention Deficit Hyperactivity DisorderPhase 1NCT01177943

A Bioequivalence (BE) Study in Healthy Subjects

A Phase 1 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
Atomoxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteJapan
Study dates
Aug 2010to Oct 2010
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).
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  • 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.
  • Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).
  • Subjects with a history of seizure, excluding febrile convulsion in childhood.
  • Exposure to a monoamine oxidase inhibitor (MAOI) drug or herbal preparations with central nervous system effects such as St. John's Wort within the last 2 weeks prior to dosing.
  • Subjects who have a history or presence of narrow-angle glaucoma.
  • Have a history or presence of significant neuropsychiatric disease (for example, maniac-depressive illness, schizophrenia, or depression).
  • Currently smoke in excess of 10 cigarettes per day, or equivalent in tobacco or nicotine substitutes, or are unwilling to stop smoking for the duration specified in the protocol
  • Subjects determined by the investigator or the sponsor to be inadequate for inclusion in this study for any other reasons.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • 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

Other trials in Japan

About this study

Official title: LY139603 Bioequivalence Study Comparing Atomoxetine Oral Solution and Capsule Formulation in Healthy Adult Male Japanese Subjects

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.

Being tested
Atomoxetine
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtomoxetineDrug

    Also called LY139603, Strattera

    Administered orally, once.

Study groups in NCT01177943
Study groupRoleWhat they receive
Atomoxetine Oral SolutionExperimentalNot described
Receives: Drug: Atomoxetine
Atomoxetine Capsule FormulationActive comparatorNot described
Receives: Drug: Atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01177943
Sponsor's protocol ID
13554
Other IDs
B4Z-JE-LYEO
Status last verified
Sep 2011
First submitted
6 Aug 2010
Last updated
27 Oct 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01177943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.

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A Bioequivalence (BE) Study in Healthy Subjects | AzTrials