LY2189265 and Atorvastatin Interaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01250834
First received: November 29, 2010
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.


Condition Intervention Phase
Healthy Volunteers
Drug: Atorvastatin
Biological: LY2189265
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of LY2189265 on the Pharmacokinetics of Atorvastatin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
    This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.


Secondary Outcome Measures:
  • Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
    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.

  • Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC) [ Time Frame: Pre-dose to 56 hours post-dose ] [ Designated as safety issue: No ]
    This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.


Enrollment: 27
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: 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.

Drug: Atorvastatin
Administered orally.
Biological: LY2189265
Administered subcutaneously.

  Eligibility

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

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
  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: NCT01250834

Locations
United Kingdom
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.
Leeds, West Yorkshire, United Kingdom, LS2 9LH
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: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01250834     History of Changes
Other Study ID Numbers: 11551, H9X-MC-GBCP, 2010-021657-39
Study First Received: November 29, 2010
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014