Hepatic InsufficiencyPhase 1NCT01475136

A Study of LY2140023 in Hepatically-Impaired Participants

A Phase 1 study testing LY2140023 in people with Hepatic Insufficiency, run by Denovo Biopharma LLC at 2 sites in 2 countries.

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 explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
What is being tested?: LY2140023
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2011to Dec 2012
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 participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023
Female participants of child-bearing potential who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last dose of LY2140023
Female participants who are postmenopausal. Postmenopausal is defined as no menses for at least 1 year, or a plasma follicle stimulating hormone (FSH) value of greater than 40 units per liter (IU/L), unless the participant is taking hormone replacement therapy
Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m^2), inclusive at the time of screening
Have clinical laboratory test results within the 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 sitting blood pressure and heart rate compatible with their disease state, as determined by the investigator

Show all 11Show fewer

Have venous access sufficient to allow for blood sampling as per the protocol
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Control participants that have normal hepatic function, as determined by medical history and physical examination
Hepatically-impaired participants that have stable hepatic impairment (for example, alcoholic, posthepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh class A, B, or C (mild, moderate, or severe impairment) who are considered acceptable for participation in the study by the investigator

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 90 days from last dosing of an investigational product (other than the investigational product used in this study); 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 to LY2140023, LY404039, related compounds, or any components of the formulation
Have previously discontinued after receiving at least 1 dose of LY2140023 or completed this study or any other study investigating LY2140023 and or LY404039
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 a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption (except cholecystectomy), metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have evidence of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, or depression)

Show all 55Show fewer

Participants who answer 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS), or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS; and the ideation or behavior occurred within the past 3 months
Have increased risk of seizures based on a history of:
One or more seizures (except for a single simple febrile seizure [lacking focality and lasting less than 15 minutes, not associated with a central nervous system (CNS) infection or severe metabolic disturbance] as a child between ages 6 months to 5 years)
Head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
CNS infection, uncontrolled migraine or transient ischemic attack (TIA) within 1 year; stroke with persistent neurological deficit (focal or diffuse). Uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning. TIA is defined as "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
CNS infection with persistent neurological deficit (focal or diffuse)
Brain surgery
Electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, sharp-slow wave complexes, or as locally defined)
Brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (does not include hydrocephalus unless treated by shunt or resulting in neurological deficits)
Known substance dependence unless approved prescription medication such as opiates, or known regular use of drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Women who are pregnant or intend to get pregnant during the study or within 3 months after the last dose of investigational product
Women who are breast feeding or lactating
Have donated blood of more than 500 milliliters (mL) within the last 3 months prior to the screening
Are organ transplant participants or have taken immunosuppressants following any organ transplant
Have shown signs of variceal bleeding during the last 2 months prior to screening (except for participants with severe hepatic impairment, detailed in exclusion criterion)
Show evidence of irritable bowel syndrome or chronic diarrhea
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), and are participants unwilling to stop alcohol consumption for 96 hours predose until after 48 hours post-dose (1 unit equals 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Have a clinically significant abnormality in the neurological examination
Participants judged prior to dosing to be at suicidal risk by the investigator
Participants who are unwilling to refrain from smoking from midnight prior to dosing until 6 hours postdose or are unable to abide by the Clinical Research Unit (CRU) restrictions
Are on total parenteral nutrition (TPN)
Take oral anticoagulants for therapeutic use
Exhibit any other condition, which, in the opinion of the investigator would preclude participation in the study
Show evidence of pruritus or skin exfoliation
Have an eosinophil count >1.5 x 10^9/liter (L)
Have electrolyte imbalance alerts (clinically significant changes in calcium magnesium, or sodium)
Control Participants:
Have any medically significant history of neurologic disease, cancer, or cardiac, respiratory, metabolic, hepatic, renal, gastrointestinal (except appendectomy), dermatological, venereal, hematological disorder or disease
Have creatinine clearance (CrCl) less than 80 milliliters per minute (mL/min), as calculated by the Cockcroft-Gault equation:
Men: [(140 - age) x (weight in kilograms [kg])] / [72 x (serum creatinine in mg/100 mL)]; or [(140 - age) x (weight in kg)] / [0.81 x (serum creatinine in micromoles per liter [μmol/L])] Women in both of the above equations: (x 0.85)
Show evidence of significant active neuropsychiatric disease in the opinion of the investigator
Evidence of hepatitis B and/or positive hepatitis B surface antigen (HBsAg)
Show evidence of hepatitis C and/or positive hepatitis C antibody
Intend to use over-the-counter medication (including herbal remedies/health supplements) within 7 days prior to dosing, or prescription medication (other than hormone replacement therapy as described above) within 14 days prior to dosing
Mild Hepatic Impaired Participants (Child-Pugh A):
show evidence of any significant active disease other than that responsible for or associated with hepatic impairment
have a platelet count of less than 50 x 10^9 cells/L, unless after consultation with the Lilly Clinical Pharmacologist (CP), they are considered as acceptable for participation in the study
Moderate and Severe Hepatic Impaired Participants (Child-Pugh B and C):
Show evidence of any significant active disease other than that responsible for or associated with moderate or severe hepatic impairment
Have shown signs of spontaneous bacterial peritonitis within 6 months prior to dosing
Have severe hyponatremia
Show evidence of significant active neuropsychiatric disease
Have hepatic encephalopathy (Grades 2 to 4)
Have hemoglobin concentrations <9.0 grams per deciliter (g/dL)
Show signs of hepatocellular carcinoma
Have a surgical portosystemic shunt
Have a platelet count of less than 40 x 10^9 cells/L (moderate impairment) or less than 30 x 10^9 cells/L (severe impairment), unless after consultation with the Lilly CP they are considered as acceptable for participation in the study
Have shown signs of variceal bleeding during the last 2 weeks prior to screening (severe hepatic impaired participants only)

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

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

Other trials in Germany

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

Other trials in Hungary

About this study

Official title: A Single Dose Pharmacokinetic Study of LY2140023 in Subjects With Hepatic Impairment

This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

Read the detailed description

The study included 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).

Conditions: Hepatic Insufficiency
Being tested: LY2140023
Medical subject headings: Hepatic Insufficiency

What participants receive

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

LY2140023Drug

Study groups in NCT01475136
Study group	Role	What they receive
LY2140023	Experimental	A single oral dose of 80 milligrams (mg) LY2140023 administered on Day 1. Receives: Drug: LY2140023

What is being measured

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

Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2140023 and LY404039
LY404039 is the active metabolite of LY2140023. AUC from zero to infinity AUC(0-∞) is presented.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2140023 and LY404039
LY404039 is the active metabolite of LY2140023.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose
Pharmacokinetics: Time of Maximal Concentration (Tmax) of LY2140023 and LY404039
LY404039 is the active metabolite of LY2140023.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose

Timeline

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

Nov 2011Dec 2012

First posted21 Nov 2011 (estimated)
Study startNov 2011
Primary completionDec 2012
Study completionDec 2012

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 Hepatic InsufficiencyStudies of the same condition, open and under way.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01475136
Sponsor's protocol ID: 12677
Other IDs: H8Y-MC-HBCH, 2011-003033-34
Status last verified: Jan 2013
First submitted: 16 Nov 2011
Last updated: 22 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Pharmacokinetic Study of LY2140023 in Subjects With Hepatic Impairment
ClinicalTrials.gov ID: NCT01475136
Acronym / sponsor ID: 12677
Conditions: Hepatic Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 21 Nov 2011 (estimated)
Results: Posted 22 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug) and its active metabolite (LY404039).

Detailed description

The study included 4 groups, based on the Child-Pugh classification of hepatic impairment as follows:

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2140023	Experimental	Drug: LY2140023A single oral dose of 80 milligrams (mg) LY2140023 administered on Day 1.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023
Female participants of child-bearing potential who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last dose of LY2140023
Female participants who are postmenopausal. Postmenopausal is defined as no menses for at least 1 year, or a plasma follicle stimulating hormone (FSH) value of greater than 40 units per liter (IU/L), unless the participant is taking hormone replacement therapy
Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m^2), inclusive at the time of screening
Have clinical laboratory test results within the 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

Key exclusion criteria (55 listed)

Are currently enrolled in, have completed or discontinued within the last 90 days from last dosing of an investigational product (other than the investigational product used in this study); 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 to LY2140023, LY404039, related compounds, or any components of the formulation
Have previously discontinued after receiving at least 1 dose of LY2140023 or completed this study or any other study investigating LY2140023 and or LY404039
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 a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption (except cholecystectomy), metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

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
LY2140023	Drug	LY2140023

Primary outcome

Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2140023 and LY404039
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose
LY404039 is the active metabolite of LY2140023. AUC from zero to infinity AUC(0-∞) is presented.
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2140023 and LY404039
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose
LY404039 is the active metabolite of LY2140023.
Pharmacokinetics: Time of Maximal Concentration (Tmax) of LY2140023 and LY404039
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose
LY404039 is the active metabolite of LY2140023.

Results and safety

Results posted to the registry on 22 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2140023-Normal Hepatic Function	7	6
LY2140023-Mild Hepatic Impairment	9	6
LY2140023-Moderate Hepatic Impairment	9	6
LY2140023-Severe Hepatic Impairment	12	7

Primary outcome: Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2140023 and LY404039

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter (ng*h/mL)

Measure	LY2140023-Normal Hepatic Function n = 5	LY2140023-Mild Hepatic Impairment n = 6	LY2140023-Moderate Hepatic Impairment n = 6	LY2140023-Severe Hepatic Impairment n = 5
LY2140023	1420 (34)	1360 (30)	836 (57)	926 (22)
LY404039	2710 (16)	3290 (28)	2570 (28)	2640 (33)

Population analysed: All participants who received 1 dose of LY2140023, did not have an incidence of vomiting within 5 hours postdose, and had evaluable AUC(0-∞) data.

Primary outcome: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2140023 and LY404039

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	LY2140023-Normal Hepatic Function n = 5	LY2140023-Mild Hepatic Impairment n = 6	LY2140023-Moderate Hepatic Impairment n = 6	LY2140023-Severe Hepatic Impairment n = 5
LY2140023	332 (27)	305 (29)	211 (41)	194 (25)
LY404039	440 (10)	517 (23)	431 (28)	403 (28)

Population analysed: All participants who received 1 dose of LY2140023, did not have an incidence of vomiting within 5 hours postdose, and had evaluable Cmax data.

Primary outcome: Pharmacokinetics: Time of Maximal Concentration (Tmax) of LY2140023 and LY404039

Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose. Median (Full Range). Unit: hours

Measure	LY2140023-Normal Hepatic Function n = 5	LY2140023-Mild Hepatic Impairment n = 6	LY2140023-Moderate Hepatic Impairment n = 6	LY2140023-Severe Hepatic Impairment n = 5
LY2140023	3.00 (2.00 to 4.00)	2.50 (2.00 to 3.00)	2.50 (1.00 to 4.00)	2.00 (2.00 to 3.00)
LY404039	4.00 (3.00 to 4.00)	4.00 (3.00 to 4.00)	3.50 (2.00 to 4.00)	4.00 (3.00 to 4.00)

Population analysed: All participants who received 1 dose of LY2140023, did not have an incidence of vomiting within 5 hours postdose, and had evaluable Tmax data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2140023-Normal Hepatic Function	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
LY2140023-Mild Hepatic Impairment	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
LY2140023-Moderate Hepatic Impairment	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
LY2140023-Severe Hepatic Impairment	0 of 7 (0%)	0 of 7 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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 LY2140023 in people with Hepatic Insufficiency, run by Denovo Biopharma LLC 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 11 inclusion and 55 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 22 Sep 2021. 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 22 Sep 2021). 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 (AUC) of LY2140023 and LY404039 (time frame: Predose and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, and 48 hours postdose). The study lists 3 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 NCT01475136.

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 22 Sep 2021.