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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

NCTNCT01301092 (opens ClinicalTrials.gov in a new tab)Other id13989Other idH9X-MC-GBDR

Overview

Status
Completed
Phase
Phase 1
Enrollment
30 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2011
Primary completion
Aug 2011
Completion
Aug 2011
First posted
23 Feb 2011 (estimated)
Last update posted
7 Oct 2014 (estimated)
Conditions
Diabetes Mellitus, Type II

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012
  1. Ph 1

    A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

    NCT01301092

    Feb 2011 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above. The study is divided into three parts, Part A, B and C. Volunteers will only be able to participate in one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of the study will occur after Part A because the dose of IV drug will depend on the results of Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the drug. Participants in Part C will also be given drug twice by an SC injection and an IM injection, both doses will be 0.75 mg.

Interventions

  • LY2189265Biological

Arms3

  • Experimental

    Part A: LY2189265 intravenous

    Single intravenous (IV) dose, starting at 0.1 milligrams (mg) of LY2189265. Dose may be increased to 0.2 mg or decreased to 0.05 mg for subsequent patients, dependent on safety assessments of the first 3 patients.

  • Experimental

    Part B: LY2189265 subcutaneous, intravenous

    Patients are randomized to 2 sequences of 2 treatments. Single 1.5 mg subcutaneous (SC) dose of LY2189265 in Period 1; single intravenous (IV) dose of LY2189265 (determined by Part A IV arm data) in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.

  • Experimental

    Part C: LY2189265 subcutaneous, intramuscular

    Patients are randomized to 2 sequences of 2 treatments. Single 0.75 mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75 mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

    Time frame · Predose up to 336 hours postdose

    Registry description

    AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.

  2. Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

    Time frame · Predose up to 336 hours postdose

    Registry description

    The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.

Secondary outcomes(2)
  1. Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)

    Time frame · Predose up to 336 hours postdose

    Registry description

    AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.

  2. )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)

    Time frame · Predose up to 336 hours postdose

    Registry description

    The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose up to 336 hours postdose

Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

GroupValue (nanograms*hour/milliliter/milligram)
Part B: LY2189265 Subcutaneous10256
Part B: LY2189265 Intravenous23150
Primary outcomeGeometric mean· Predose up to 336 hours postdose

Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

GroupValue (nanograms/milliliter (ng/mL))
Part B: LY2189265 Subcutaneous80.7
Part B: LY2189265 Intravenous38.3
Secondary and other outcome results(2)
Secondary outcomeGeometric mean· Predose up to 336 hours postdose

Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)

GroupValue (nanograms*hour/milliliter (ng*h/mL))
Part C: LY2189265 Intramuscular9828
Part C: LY2189265 Subcutaneous10215
Secondary outcomeGeometric mean· Predose up to 336 hours postdose

)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)

GroupValue (nanograms/milliliter (ng/mL))
Part C: LY2189265 Intramuscular56.9
Part C: LY2189265 Subcutaneous54.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part A: 0.1 mg IV LY2189265Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265–0 / 60 / 6
Part B: 0.1 mg IV LY2189265Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.–0 / 167 / 16
Part B: 1.5 mg SC LY2189265Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.–0 / 169 / 16
Part C: 0.75 mg IM LY2189265Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.–0 / 83 / 8
Part C: 0.75 mg SC LY2189265Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.–0 / 82 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination. * Male subjects with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following: condom with spermicidal agent, male subject sterilization, true abstinence (which is in line with the subject's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable). * Female subjects not of child-bearing potential (that is, are postmenopausal or permanently sterilized \[for example, tubal occlusion, hysterectomy, bilateral salpingectomy\]). Such subjects will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) with follicle stimulating hormone (FSH) greater than or equal to 40 milli-international units per milliliter (mIU/mL). * Female subjects who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such subjects must also test negative for pregnancy at the time of enrollment. * Have a body mass index (BMI) of between 23.0 and 35.0 kilogram/square meter (kg/m²), inclusive. * 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 normal sitting blood pressure and pulse rate as determined by the investigator, or with changes compatible with their age. * Have venous access sufficient to allow for blood sampling and/or IV administration of investigational product as per the protocol. * 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 are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Are women of child bearing potential * Have known allergies to Glucagon-like peptide-1 (GLP-1)-related compounds including LY2189265. * Are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265. * 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 or presence of gastrointestinal disorder (including pancreatitis \[history of chronic pancreatitis or idiopathic acute pancreatitis\] or gall bladder disease), or gastrointestinal disease that impacts gastric emptying (GE) (for example, gastric bypass surgery, pyloric stenosis) or could be aggravated by GLP analogs (for example, esophageal reflux). Subjects having had cholecystolithiasis (removal of gall stones), cholecystectomy (removal of gall bladder) and/or appendectomy 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 significant active neuropsychiatric disease * 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. * Use or intend to use over-the-counter medication other than paracetamol 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. * Have donated blood of more than 500 mL within the last month. * Are subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), (1 unit = 12 ounce \[oz\] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits), or are unwilling to stop alcohol consumption from at least 24 hours prior to screening and each dose, and while resident at the clinical research unit (CRU). * Are subjects who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration and while resident. * Are subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

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