- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250834
LY2189265 and Atorvastatin Interaction Study
October 3, 2014 updated by: Eli Lilly and Company
Effect of LY2189265 on the Pharmacokinetics of Atorvastatin in Healthy Subjects
This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS2 9LH
- 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.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male subjects with female partners of child-bearing potential: Agree and whose partners agree to use two reliable methods of contraception from the time of the first dose until 3 months after the last dose of study drug, as determined by the investigator.
- Female subjects not of child-bearing potential (that is, are postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]) will not be required to use contraception. 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 milliInternational Units per milliliter (mIU/mL).
- Female subjects who have undergone sterilization by tubal ligation: Agree to use a male or female condom used in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of study drug. Such subjects must also test negative for pregnancy at the time of enrollment.
- Have a body mass index (BMI) between 18.5 and 30.0 kilograms per square meter (kg/m^2), 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 venous access sufficient to allow frequent blood sampling.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow the study restrictions
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 90 days from a clinical trial involving an investigational drug or device or off-label use of a 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 or intolerance to atorvastatin.
- 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 have taken part in any other study investigating LY2189265 or GLP-1-related compounds or incretin mimetics within the last 3 months.
- 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 an abnormal blood pressure (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study.
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts absorption and distribution of study drugs (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs.
- Have a history or presence of thyroid disease.
- Show history or evidence 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.
- Intend to use over-the-counter medication within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy) within 14 days prior to dosing.
- Use drugs that are known substrates, inducers, or inhibitors of cytochrome P450 (CYP) enzyme pathways or phosphorylated glycoprotein (P-gp) within 14 days prior to the first dose.
- Have donated blood of more than 500 mL within the month prior to screening.
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), and are subjects unwilling to stop alcohol consumption from 48 hours before Admission (Day -1) until discharge from the unit for each treatment period, and to limit alcohol intake to a maximum of 2 units/day on all other days from screening through 48 hours prior to the post-study visit (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).
- Are subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.
- Are women of child bearing potential
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LY2189265 + Atorvastatin
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Period 1 and Period 2. Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. |
Administered orally.
Administered subcutaneously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)
Time Frame: Pre-dose to 56 hours post-dose
|
Pre-dose to 56 hours post-dose
|
|
Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)
Time Frame: Pre-dose to 56 hours post-dose
|
This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.
|
Pre-dose to 56 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Time Frame: Pre-dose to 56 hours post-dose
|
Pre-dose to 56 hours post-dose
|
|
Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)
Time Frame: Pre-dose to 56 hours post-dose
|
This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity.
The outcome is not available for this metabolite since the terminal elimination phase was not determinable.
|
Pre-dose to 56 hours post-dose
|
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Time Frame: Pre-dose to 56 hours post-dose
|
Pre-dose to 56 hours post-dose
|
|
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)
Time Frame: Pre-dose to 56 hours post-dose
|
This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.
|
Pre-dose to 56 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
November 29, 2010
First Posted (ESTIMATE)
December 1, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 8, 2014
Last Update Submitted That Met QC Criteria
October 3, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11551 (DAIDS ES Registry Number)
- H9X-MC-GBCP (OTHER: Eli Lilly and Company)
- 2010-021657-39 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Atorvastatin
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2Korea, Republic of, Malaysia, Philippines, Thailand, Russian Federation, Mexico
-
Organon and CoCompleted
-
Obafemi Awolowo University Teaching HospitalOpen PhilanthropyRecruitingTuberculosis | Pulmonary Tuberculosis | Koch's DiseaseNigeria
-
Hippocration General HospitalCompletedCoronary Artery Disease | Atherosclerosis | Endothelial Dysfunction | Oxidative Stress | HMG-CoA Reductase Inhibitor ToxicityGreece
-
PfizerCompletedHypertriglyceridemia | Hyperlipoproteinemia Type IVUnited States, Canada
-
Organon and CoCompleted
-
Zhejiang Hisun Pharmaceutical Co. Ltd.Unknown
-
St. Olavs HospitalUllevaal University Hospital; Oslo University Hospital; University Hospital of... and other collaboratorsNot yet recruiting
-
Zhongda HospitalNot yet recruitingAcute Ischemic Stroke | Mechanical ThrombectomyChina