A Study of LY2216684 in Healthy Subjects Receiving Albuterol or Propanolol

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01263197
First received: December 16, 2010
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine the effect of LY2216684 on heart rate of healthy people receiving Albuterol and Propranolol. Information about any side effects that may occur will also be collected.


Condition Intervention Phase
Major Depressive Disorder
Drug: LY2216684
Drug: albuterol
Drug: propranolol
Drug: placebo for LY2216684
Drug: placebo for albuterol
Drug: placebo for propranolol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of LY2216684 on Heart Rate and Blood Pressure in Healthy Subjects Receiving Oral Doses of Albuterol or Propranolol

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Maximum, minimum and average changes in heart rate [ Time Frame: Baseline, Day 1, 3 and 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum, minimum and average changes in blood pressure [ Time Frame: Baseline, Day 1, 3, and 5 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2216684, albuterol, LY221684+albuterol
LY2216684 as an 18 mg oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in first intervention period, placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: albuterol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for albuterol
administered orally
Experimental: albuterol, LY2216684+albuterol, LY2216684
Placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: albuterol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for albuterol
administered orally
Experimental: LY2216684+albuterol, LY2216684, albuterol
LY2216684 as an 18 mg oral dose on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and placebo for albuterol on days 1, 3 and 5 in second intervention period, Placebo for LY2216684 on days 1-5 and albuterol as a 2 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: albuterol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for albuterol
administered orally
Experimental: LY2216684, propranolol, LY2216684+propranolol
LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in first intervention period, placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: propranolol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for propranolol
administered orally
Experimental: propranolol, LY2216684+propranolol, LY2216684
Placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the second intervention period, and LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: propranolol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for propranolol
administered orally
Experimental: LY2216684+propranolol, LY2216684, propranolol
LY2216684 as an 18 mg oral dose on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the first intervention period, LY2216684 as an 18 mg oral dose on days 1-5 and placebo for propranolol on days 1, 3 and 5 in second intervention period, placebo for LY2216684 on days 1-5 and propranolol as a 40 mg oral dose on days 1, 3 and 5 in the third intervention period. There is a 7 day washout between each intervention period.
Drug: LY2216684
administered orally
Drug: propranolol
administered orally
Drug: placebo for LY2216684
administered orally
Drug: placebo for propranolol
administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy, as determined by medical history and physical examination.
  • Male subjects - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
  • Female subjects - Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mIU/mL).
  • Have a body weight >50 kg.
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  • Have venous access sufficient to allow blood sampling as per the protocol.
  • Have normal blood pressure and pulse rate (sitting position) as determined 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 (ERB) governing the site.

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug, 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 LY2216684, albuterol (Group 1 only), propranolol (Group 2 only), or related compounds.
  • Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening.
  • Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
  • Have a history of or current asthma, including exercised induce asthma.
  • Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation.
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
  • Show evidence of hepatitis C and/or positive hepatitis C antibody.
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
  • Are women with a positive pregnancy test or women who are lactating.
  • Intend to use over-the-counter or prescription medication (including hormonal contraceptives) within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor
  • Have donated blood of more than 500 mL within the last month.
  • Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to check-in in each period and while resident at the CRU (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  • Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any subjects unwilling to adhere to study caffeine restrictions.
  • Have used any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to enrollment.
  • Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment and during the study.
  • Have a documented or suspected history of glaucoma.
  • Subjects determined to be unsuitable by the investigator for any reason.
  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: NCT01263197

Locations
United States, Indiana
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.
Evansville, Indiana, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01263197     History of Changes
Other Study ID Numbers: 12598, H9P-EW-LNCI
Study First Received: December 16, 2010
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Albuterol
Phenylethyl Alcohol
Propranolol
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antihypertensive Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Disinfectants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 29, 2014