LY2189265 and Atorvastatin Interaction Study

Healthy Volunteers Clinical Trial

Official title:

Effect of LY2189265 on the Pharmacokinetics of Atorvastatin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250834
• Other study ID #: 11551
• Secondary ID: H9X-MC-GBCP2010-
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2010
• Last updated: October 3, 2014
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Atorvastatin
Administered orally.

Biological:
• LY2189265
Administered subcutaneously.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)		Pre-dose to 56 hours post-dose	No
Primary	Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)	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	No
Secondary	Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)		Pre-dose to 56 hours post-dose	No
Secondary	Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)	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	No
Secondary	Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)		Pre-dose to 56 hours post-dose	No
Secondary	Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)	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	No