Healthy VolunteersPhase 1NCT01751399
A Single Dose Study of LY2605541 in Participants With Liver Impairment
A Phase 1 study testing LY2605541 in people with Healthy Volunteers and Hepatic Insufficiency, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The primary purpose of this study is to help answer the following research questions: To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function To assess the safety of LY2605541 and any side effects that… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hepatic Insufficiency, Diabetes Mellitus, Type 2
- What is being tested?
- LY2605541
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2012to Sep 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants (including those with type 2 diabetes mellitus [T2DM] who are controlled by diet)
- Male participants agree to use a reliable method of birth control during the study
- Female participants of child-bearing potential (not surgically sterilized between menarche and menopause) must have a negative pregnancy test at the time of enrollment and must be using a reliable method of birth control
- Women of non-child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or menopause.
- Menopausal women include women with either spontaneous amenorrhea for at least 12 months or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 milli international units per milliliter (mIU/mL)
- Have a body mass index (BMI) of 18.5 to 40 kilogram per square meter (kg/m^2)
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- Have normal sitting blood pressure and heart rate compatible with their disease state
- Have venous access sufficient to allow blood sampling
- Have given written informed consent approved by Lilly and the Ethical Review Board (ERB) governing the site
- Participants with Normal Hepatic Function
- Overtly healthy males or females with normal hepatic function
- Have clinical laboratory test results within normal reference range for the investigator site, or results with minor deviations not considered to be clinically significant by the investigator
- Participants with Hepatic Impairment
- Have stable liver impairment with no sign of recent deterioration (alcoholic, posthepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh class A, B, or C who are considered by the investigator as acceptable for participation in the study
Who cannot join
- All Participants (including those with T2DM)
- Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have an acute infection with fever or infectious disease or febrile illness within 3 days prior to administration of the study medication
- Have known allergies or significant hypersensitivity to LY2605541, its excipients, or related compounds, or history of relevant allergic reactions of any origin
- Have previously completed or withdrawn from this study or any other study investigating LY2605541 and have previously received the investigational product
- Have Type 1 Diabetes Mellitus (T1DM) or have T2DM and are receiving anti-diabetic medication
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- 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
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have had a liver transplant or have taken immunosuppressants following any organ transplant
- Have shown signs of variceal bleeding during the last 2 weeks prior to screening
- Show evidence of irritable bowel syndrome, chronic diarrhea, other symptomatic digestive problems or a known history of repeated chronic stool positive for occult blood, or be considered by the investigator to be at greater risk of acute or chronic pancreatitis
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption for the duration of the study (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 on total parenteral nutrition
- Take anticoagulants for therapeutic use, other than low dose acetylsalicyclic acid
- Are excessive consumers of xanthines
- Participants with Normal Hepatic Function
- Have any medically significant history of neurologic disease, cancer, or cardiac, respiratory, metabolic, hepatic, renal, gastrointestinal (except appendectomy and cholecystectomy), dermatological, venereal, hematological disorder or disease
- Have creatinine clearance (CrCl) less than 80 milliliters per minute (mL/min)
- Show evidence of significant active neuropsychiatric disease in the opinion of the investigator
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Participants with Hepatic Impairment
- Show evidence of any significant active disease other than that responsible for or associated with mild, moderate, or severe hepatic impairment
- Show evidence of hepatorenal syndrome as shown by CrCl <50 mL/min calculated using the Cockcroft-Gault equation
- Have shown signs of spontaneous bacterial peritonitis within 6 months prior to enrollment into the study
- Have severe hyponatremia (sodium <120 millimoles per liter [mmol/L])
- Show signs of hepatocellular carcinoma
- Have a portal shunt
- Show, in the opinion of the investigator, evidence of significant active neuropsychiatric disease other than grade 1 hepatic encephalopathy
- Have hemoglobin concentrations <9.0 grams per deciliter (g/dL)
- Have a platelet count of <30 x 10^9 cells per liter (cells/L), unless, after consultation with the sponsor, they are considered as acceptable for participation in the study
- Have total serum bilirubin concentrations >15 milligrams per deciliter (mg/dL) (>257 micromoles per liter [μmol/L])
- Take medications known to interfere with hepatic metabolism (for example barbiturates or phenothiayines) or known to alter other major organ systems
- Show signs of acute cholestasis or acute cholecystitis
- Have severe ascites
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 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.
Munich, 81241
Hungary1 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.
Balatonfüred, 8230
About this study
Official title: A Single Dose Pharmacokinetic Study of LY2605541 in Subjects With Hepatic Impairment
The primary purpose of this study is to help answer the following research questions:
- To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function
- To assess the safety of LY2605541 and any side effects that might be associated with it
Read the detailed description
The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:
Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).
- Being tested
- LY2605541
- Medical subject headings
- Hepatic Insufficiency, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2605541Drug
| Study group | Role | What they receive |
|---|---|---|
| LY2605541-Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541 Receives: Drug: LY2605541 |
| LY2605541-Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 Receives: Drug: LY2605541 |
| LY2605541-Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 Receives: Drug: LY2605541 |
| LY2605541-Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 Receives: Drug: LY2605541 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751399
- Sponsor's protocol ID
- 14205
- Other IDs
- I2R-MC-BIDA
- Status last verified
- Mar 2018
- First submitted
- 14 Dec 2012
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Pharmacokinetic Study of LY2605541 in Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT01751399
- Acronym / sponsor ID
- 14205
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to help answer the following research questions:
- To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function
- To assess the safety of LY2605541 and any side effects that might be associated with it
Detailed description
The study is conducted in 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:
Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment (Child-Pugh class C).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY2605541-Normal Hepatic Function | Experimental | Drug: LY2605541Participants with normal hepatic function will receive a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541 |
| LY2605541-Mild Hepatic Impairment | Experimental | Drug: LY2605541Participants with mild hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
| LY2605541-Moderate Hepatic Impairment | Experimental | Drug: LY2605541Participants with moderate hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
| LY2605541-Severe Hepatic Impairment | Experimental | Drug: LY2605541Participants with severe hepatic impairment will receive a single SC dose of 0.075 mg/kg LY2605541 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All Participants (including those with type 2 diabetes mellitus [T2DM] who are controlled by diet)
- Male participants agree to use a reliable method of birth control during the study
- Female participants of child-bearing potential (not surgically sterilized between menarche and menopause) must have a negative pregnancy test at the time of enrollment and must be using a reliable method of birth control
- Women of non-child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or menopause.
- Menopausal women include women with either spontaneous amenorrhea for at least 12 months or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level greater than 40 milli international units per milliliter (mIU/mL)
Key exclusion criteria (37 listed)
- All Participants (including those with T2DM)
- Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have an acute infection with fever or infectious disease or febrile illness within 3 days prior to administration of the study medication
- Have known allergies or significant hypersensitivity to LY2605541, its excipients, or related compounds, or history of relevant allergic reactions of any origin
- Have previously completed or withdrawn from this study or any other study investigating LY2605541 and have previously received the investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2605541 | Drug | LY2605541-Mild Hepatic Impairment, LY2605541-Moderate Hepatic Impairment, LY2605541-Normal Hepatic Function, LY2605541-Severe Hepatic Impairment |
Primary outcome
Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2605541 in people with Healthy Volunteers and Hepatic Insufficiency, run by Eli Lilly and Company at 2 sites in 2 countries.
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 14 inclusion and 37 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Hungary. 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 19 Oct 2018). 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: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541 (time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose). 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?
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 19 Oct 2018.