A Study of LY2216684 in Healthy Participants Receiving Albuterol or Propanolol
Effect of LY2216684 on Heart Rate and Blood Pressure in Healthy Subjects Receiving Oral Doses of Albuterol or Propranolol
2 other identifiers
interventional
48
1 country
1
Brief Summary
The purpose of this study is to determine the effect of LY2216684 on heart rate of participants receiving Albuterol and Propranolol. Information about any side effects that may occur will also be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 major-depressive-disorder
Started Dec 2010
Shorter than P25 for phase_1 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 16, 2010
CompletedFirst Posted
Study publicly available on registry
December 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
October 22, 2018
CompletedJanuary 29, 2019
January 1, 2019
3 months
December 16, 2010
February 17, 2018
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum, Minimum and Average Changes in Heart Rate
Using a Holter monitor, heart rate was recorded every 10 minutes through 24 hours postdose on Days 1, 3, and 5 of each period. Baseline heart rate was the average of 10-minute readings taken over 2 hours prior to dosing on Day 1 of each period. Postdose heart rate was summarized over 1-hour increments using the average of the 10-minute readings within these intervals. The postdose heart rate for a day was the average heart rate for 24 hours. The least squares (LS) mean change from baseline heart rate is reported. LS mean was calculated using a mixed effects model and adjusted for participant, sequence, period, time, treatment, and time by treatment interaction.
Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 10 minutes through 24 hours postdose)
Secondary Outcomes (2)
Maximum, Minimum and Average Changes in Systolic Blood Pressure
Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)
Maximum, Minimum and Average Changes in Diastolic Blood Pressure
Period 1, 2, 3: Baseline, Days 1 and 3 and 5 (postdose every 15 minutes from 0600 hours through 2200 hours and every hour from 2200 hours through 0600 hours)
Study Arms (6)
LY2216684, albuterol, LY2216684+albuterol
EXPERIMENTALLY2216684 as an 18 milligram (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 minimum 7 day washout between each intervention period.
albuterol, LY2216684+albuterol, LY2216684
EXPERIMENTALPlacebo 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 minimum 7 day washout between each intervention period.
LY2216684+albuterol, LY2216684, albuterol
EXPERIMENTALLY2216684 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 minimum 7 day washout between each intervention period.
LY2216684, propranolol, LY2216684+propranolol
EXPERIMENTALLY2216684 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 minimum 7 day washout between each intervention period.
propranolol, LY2216684+propranolol, LY2216684
EXPERIMENTALPlacebo 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 minimum 7 day washout between each intervention period.
LY2216684+propranolol, LY2216684, propranolol
EXPERIMENTALLY2216684 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 minimum 7 day washout between each intervention period.
Interventions
administered orally
administered orally
administered orally
administered orally
administered orally
administered orally
Eligibility Criteria
You may qualify if:
- Are overtly healthy, as determined by medical history and physical examination.
- Male participants - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- Female participants - 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 \[at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) \>40 milli-international units per milliliter (mIU/mL)\].
- Have a body weight \>50 kilograms (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.
You may not qualify if:
- 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 electrocardiogram (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 exercise induced 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 milliliters (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 Clinical Research Unit (CRU) \[1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits\].
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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.
Evansville, Indiana, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2010
First Posted
December 20, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
January 29, 2019
Results First Posted
October 22, 2018
Record last verified: 2019-01