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Healthy VolunteersPhase 1NCT01250834

LY2189265 and Atorvastatin Interaction Study

A Phase 1 study testing Atorvastatin and LY2189265 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Atorvastatin and LY2189265
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2010to Mar 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • 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, LS2 9LH

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Atorvastatin, LY2189265

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Administered orally.

  • LY2189265Biological

    Administered subcutaneously.

Study groups in NCT01250834
Study groupRoleWhat they receive
LY2189265 + AtorvastatinExperimentalPeriod 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.
Receives: Drug: Atorvastatin; Biological: LY2189265

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)

    Measured: Pre-dose to 56 hours post-dose

  2. 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.

    Measured: Pre-dose to 56 hours post-dose

Secondary outcomes (4)

  1. Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)

    Measured: Pre-dose to 56 hours post-dose

  2. 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.

    Measured: Pre-dose to 56 hours post-dose

  3. Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)

    Measured: Pre-dose to 56 hours post-dose

  4. 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.

    Measured: Pre-dose to 56 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250834
Sponsor's protocol ID
11551
Other IDs
H9X-MC-GBCP, 2010-021657-39
Status last verified
Oct 2014
First submitted
29 Nov 2010
Last updated
8 Oct 2014
Data monitoring committee
No

Publications

  • de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.

    PubMed 28357715

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atorvastatin and LY2189265 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax) (time frame: Pre-dose to 56 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01250834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.

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LY2189265 and Atorvastatin Interaction Study | AzTrials