Expired Study
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Honolulu, Hawaii 96813


Purpose:

The purpose of this study is twofold: 1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in patients with high blood pressure who are currently taking lisinopril. 2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers when taken with a Beta-blocker drug (metoprolol). In Part 1 patients will receive four weekly injections of LY2189265 with continued use of normal lisinopril therapy. Part 2 is a cross-over study design. Patients will receive a single injection of LY2189265 in one period, and seven daily doses of metoprolol and a single injection of LY2189265 in another period.


Criteria:

Inclusion Criteria: - Male subjects: agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product - Female subjects: women not of child-bearing potential due to menopause or surgical sterilization (at least 6 weeks post surgical bilateral oophorectomy, hysterectomy or tubal ligation)confirmed by medical history - Have a body mass index (BMI) of 18.5 to 40.0 kg/m2, inclusive at the time of screening - 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 for blood sampling as per the protocol - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions - Have given written informed consent on an informed consent form (ICF) approved by Lilly and the corresponding ethics committee (EC) or ethical review board (ERB) governing the site Part 1 - Have controlled mild to moderate hypertension (supine BP less than or equal to 140/90 mmHg at screening, or results with acceptable deviations that are judged not to be clinically significant by the investigator). Males and females with stable medical problems (including T2DM) that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data may be included - Have been on oral antihypertensive medication (lisinopril QD) for at least 3 months prior to screening, have been on a stable dose for at least 1 month prior to screening, and are, in the investigator's opinion, able to safely adhere to a daily (QD) morning dosing regimen. Additional medication may be permitted as indicated Type 2 Diabetes Mellitus (T2DM) Subjects (Part 1 only) - Have T2DM controlled with diet or exercise alone or stable on a single oral agent antihyperglycemic medication (metformin, sulfonylureas, repaglinide, nateglinide, acarbose [or other disaccharidase inhibitors] or thiazolidinediones) for at least 3 weeks (3 months for thiazolidinediones) prior to admission - Have an HbA1c value of 6.0% to 9.5% at screening or within 4 weeks prior to screening - Clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable Part 2 - Are overtly healthy, as determined by medical history and physical examination Exclusion Criteria: - Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; 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 GLP-1-related compounds, including LY2189265, or any components of the formulation - Are persons who have previously completed or withdrawn from this study, or have taken part in any other study investigating LY2189265 or GLP-1-related compounds within the last 3 months - 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 or presence of gastrointestinal disorder (including pancreatitis [history of chronic pancreatitis or idiopathic acute pancreatitis] or gall bladder disease) or gastrointestinal disease that impacts GE (e.g. gastric bypass surgery, pyloric stenosis) or could be aggravated by GLP-1 analogs (for example;esophageal reflux). Subjects having had cholecystectomy (removal of gall bladder) in the past with no further sequelae, may be included in the study at the discretion of the screening physician - Have a history or presence of thyroid disease, unless have been on a stable dose of thyroxine replacement therapy for at least 1 month - Show history or evidence of significant active neuropsychiatric disease - Have personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC - Regularly use known drugs of abuse and/or show positive findings on urinary drug screening - Show evidence of human immunodeficiency virus (HIV) infection 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 - Intend to start new concomitant medication during the study, including over-the-counter and herbal medication, use drugs that directly reduce gastrointestinal motility or who regularly use systemic corticosteroids, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption - Have donated more than 500 mL of blood within the month prior to screening - Have a nondominant arm circumference of greater than 42 cm - Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from 48 hours before each admission until discharge from the unit, and to limit alcohol intake to a maximum of 2 units/day on all other days from screening through 48 hours prior to the follow-up visit. (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) - Are subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study Part 1 only: - Have any medical conditions, medical history or are taking any medication which are contraindicated within the lisinopril product information leaflet Part 2 only: - Intend to use over-the-counter medication (with the exception of paracetamol and/or antacids) within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy and/or thyroid replacement therapy) within 14 days prior to dosing of the investigational product - Have any medical conditions, medical history or are taking any medication which are contraindicated within the metoprolol product information leaflet


Study is Available At:


Original ID:

11552


NCT ID:

NCT01324388


Secondary ID:

H9X-MC-GBCO


Study Acronym:


Brief Title:

A Study of the Effect of LY2189265 on Two Blood Pressure Drugs


Official Title:

Pharmacokinetic and Pharmacodynamic Effect of LY2189265 on Lisinopril in Subjects With Hypertension and Metoprolol in Healthy Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Anticipated


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:March 2011
Completion Date:August 2011
Completion Type:Actual
Primary Completion Date:August 2011
Primary Completion Type:Actual
Verification Date:October 2011
Last Changed Date:October 12, 2011
First Received Date:March 25, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pharmacokinetics, Maximum concentration (Cmax) of metoprolol
Time Frame:Day 4 and Day 7 of metoprolol treatment period
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics, area under the concentration curve (AUC) of metoprolol when administered with LY2189265
Time Frame:Day 4 and Day 7 of metoprolol treatment period
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Mean, 24-hour blood pressure (collected by ABPM) in response to co-administration of LY2189265 and lisinopril
Time Frame:Baseline, Day 3, Day 24
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Mean, 24-hour heart rate (collected by ABPM) in response to co-administration of LY2189265 and lisinopril
Time Frame:Baseline, Day 3, Day 24
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Mean, 24-hour blood pressure (collected by ABPM) in response to co-administration of LY2189265 and metoprolol
Time Frame:Baseline, Day 4, Day 7 of metoprolol treatment period
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Mean, 24-hour heart rate (collected by ABPM - Ambulatory Blood Pressure Monitoring) in response to co-administration of LY2189265 and metoprolol
Time Frame:Baseline, Day 4, Day 7 of metoprolol treatment period
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Pharmacokinetics, Maximum concentration (Cmax) of lisinopril
Time Frame:Baseline, Day 3, Day 24
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Pharmacokinetics, area under the concentration curve (AUC) of lisinopril
Time Frame:Baseline, Day 3, Day 24
Safety Issues:True

Study Interventions

Intervention Type:Biological
Name:LY2189265
Description:administered subcutaneously
Arm Name:LY2189265 + lisinopril
Intervention Type:Drug
Name:metoprolol
Description:administered orally
Arm Name:LY2189265/Metoprolol + LY2189265
Intervention Type:Drug
Name:lisinopril
Description:administered orally
Arm Name:LY2189265 + lisinopril
Intervention Type:Drug
Name:placebo
Description:administered subcutaneously
Arm Name:Placebo + lisinopril

Study Arms

Study Arm Type:Experimental
Arm Name:LY2189265 + lisinopril
Description:1.5 mg LY2189265 administered subcutaneously, weekly for 4 weeks and lisinopril administered orally daily in the morning for 25 days, dose as prescribed by patient's established course of therapy
Study Arm Type:Placebo Comparator
Arm Name:Placebo + lisinopril
Description:placebo administered subcutaneously, weekly for 4 weeks and lisinopril administered orally daily in the morning for 25 days, dose as prescribed by patient's established course of therapy
Study Arm Type:Experimental
Arm Name:LY2189265/Metoprolol + LY2189265
Description:Single 1.5 mg dose of LY2189265 administered subcutaneously on day 1 in treatment period 1 then 100 mg metoprolol administered orally, daily for seven days and a single 1.5 mg dose of LY2189265 administered subcutaneously prior to the metoprolol on day 5 in treatment period 2. There is a washout period of at least 21 days between treatment periods.
Study Arm Type:Experimental
Arm Name:Metoprolol + LY2189265/LY2189265
Description:100 mg metoprolol administered orally, daily for seven days and a single 1.5 mg dose of LY2189265 administered subcutaneously prior to the metoprolol on day 5 in treatment period 1 then a single 1.5 mg dose of LY2189265 administered subcutaneously on day 1 in treatment period 2. There is a washout period of at least 21 days between treatment periods.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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