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InsomniaPhase 1NCT01257178

A Study to Evaluate the Pharmacokinetics of LY2624803 in Subjects With Hepatic Impairment

A Phase 1 study testing LY2624803 in people with Insomnia, run by Eli Lilly and Company at 4 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the impact of hepatic dysfunction on the pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Insomnia
What is being tested?
LY2624803
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesin 3 countries
Study dates
Nov 2010to Nov 2010
Phase
Phase 1
Are there results?
None posted in the registry

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 Subjects
  • Sexually active male and female subjects and their partners must agree to use 2 methods of contraception such as condom or occlusive cap (diaphragm or cervical/vault caps) together with spermicidal foam/gel/film/cream/suppository, from the time the subject enters the study until 3 months after the final dosing occasion, unless the male subject or partner has been sterilized (with confirmed azoospermia).
  • Have a BMI between 18.5 and 35.0 kg/m2, inclusive.
  • Have a body weight >50 kg.
  • Have normal sitting blood pressure and heart rate compatible with their disease state, as determined by the investigator.
  • Have venous access sufficient to allow blood sampling as per the protocol.
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  • 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 governing the site.
  • Control Subjects
  • Are males or females and with normal hepatic function, as determined by medical history and physical examination.
  • 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.
  • Hepatic Impaired Subjects
  • •Have stable hepatic impairment (alcoholic, posthepatitis, biliary cirrhosis, cryptogenic) classified as Child-Pugh class A, B, or C (mild, moderate, and severe impairment) who are considered acceptable for participation in the study by the investigator.

Who cannot join

  • All Subjects
  • Are currently enrolled in, or discontinued within the last 90 days from the last dosing occasion in a clinical trial involving an investigational 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 to LY2624803 or related compounds.
  • Have previously discontinued from this study or any other study investigating LY2624803.
  • Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk associated with participating in the study.
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
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  • Show evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies.
  • Have donated blood of more than 500 mL within the last 3 months prior to the screening visit.
  • Use drugs or herbal remedies that are known inhibitors or inducers of CYP3A4 or inhibitors of CYP2D6 enzyme pathways, unless in the opinion of the sponsor and investigator the medication will not compromise safety.
  • Are liver transplant subjects 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 or chronic diarrhea.
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), and are subjects unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  • Are unable to swallow whole capsules.
  • Are on total parenteral nutrition (TPN).
  • Take anticoagulants for therapeutic use.
  • Have a history of breast cancer.
  • Exhibit any other condition, which, in the opinion of the investigator would preclude participation in the study.
  • Control Subjects
  • 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) <80 mL/min, as calculated by Cockcroft-Gault equation.
  • 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 (HBsAg).
  • Show evidence of hepatitis C and/or positive hepatitis C antibody.
  • Mild Hepatic Impaired Subjects (Child-Pugh A)
  • Show evidence of any significant active disease other than that responsible for or associated with hepatic impairment.
  • Show evidence of active renal disease with creatinine clearance <70 mL/min as calculated by Cockcroft-Gault equation.
  • Have severe ascites.
  • Moderate and Severe Hepatic Impaired Subjects (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.
  • Show evidence of hepatorenal syndrome as shown by creatinine clearance <50 mL/min, as calculated by the Cockcroft-Gault equation.
  • Have shown signs of spontaneous bacterial peritonitis within 6 months prior to dosing.
  • Have severe hyponatremia.
  • Have hepatic encephalopathy (grade 2 to 4 encephalopathy).
  • 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 severe ascites.
  • Have hemoglobin concentrations <9.0 g/dL.
  • Have a platelet count of <50 x 109 cells/L, unless, after consultation with the sponsor, they are considered as acceptable for participation in the study.
  • Have total serum bilirubin concentrations >15 mg/dL (>257 µmol/L).
  • Take medications known to interfere with hepatic metabolism (for example barbiturates, phenothiazines) or known to alter other major organ systems.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Germany2 sites

  • 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.

    Mitte

  • 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.

    München

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.

    Debrecen

Other trials in Hungary

Russia1 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.

    Moscow

Other trials in Russia

About this study

Official title: A Single Dose Pharmacokinetics Study of LY2624803 in Subjects With Hepatic Impairment

The purpose of this study is to evaluate the impact of hepatic dysfunction on the pharmacokinetics and safety of LY2624803 and its major metabolite, LSN2797276.

Conditions
Insomnia
Being tested
LY2624803
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

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

  • LY2624803Drug

    Administered orally

Study groups in NCT01257178
Study groupRoleWhat they receive
Normal hepatic functionExperimental6mg, oral, once on day 1
Receives: Drug: LY2624803
Mild hepatic impairmentExperimental6 mg, oral, once on day 1
Receives: Drug: LY2624803
Moderate hepatic impairmentExperimental6 mg, oral, once on day 1
Receives: Drug: LY2624803
Severe hepatic impairmentExperimental6 mg, oral, once on day 1
Receives: Drug: LY2624803

What is being measured

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

  1. LY2624803 and the metabolite LSN2797276 Area under the Curve from time 0 to infinity [AUC(0-∞)]

    Measured: Predose through 120 hours post dose

  2. LY2624803 and the metabolite LSN2797276, Maximum Concentration (Cmax)

    Measured: Predose through 120 hours post dose

  3. LY2624803 and the metabolite LSN2797276, Time to maximum plasma concentration(tmax)

    Measured: Predose through 120 hours post dose

Secondary outcomes (6)

  1. LY2624803 and the metabolite LSN2797276, Elimination half live (t1/2)

    Measured: Predose through 120 hours post dose

  2. LY2624803 and the metabolite LSN2797276, AUC to the last quantifiable sample [AUC(0-tlast)]

    Measured: Predose through 120 hours post dose

  3. LY2624803 and the metabolite LSN2797276, Apparent clearance (CL/F)

    Measured: Predose through 120 hours post dose

  4. LY2624803 and the metabolite LSN2797276, Apparent volume of distribution (V/F)

    Measured: Predose through 120 hours post dose

  5. LY2624803 and the metabolite LSN2797276, Parent to metabolite ratios (MR) of Cmax

    Measured: Predose through 120 hours post dose

  6. LY2624803 and the metabolite LSN2797276, Parent to metabolite ratios (MR) of AUC

    Measured: Predose through 120 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 posted9 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: Trial was Terminated prior to subjects receiving study drug; no trial results

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257178
Sponsor's protocol ID
12809
Other IDs
I2K-MC-ZZBL
Status last verified
Jun 2011
First submitted
7 Dec 2010
Last updated
3 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2624803 in people with Insomnia, run by Eli Lilly and Company at 4 sites in 3 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 13 inclusion and 42 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: stopped early, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany, Hungary, Russia. 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?

The study was stopped early (reason given: Trial was Terminated prior to subjects receiving study drug; no trial results). Results are not available in the source record.

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?

LY2624803 and the metabolite LSN2797276 Area under the Curve from time 0 to infinity [AUC(0-∞)] (time frame: Predose through 120 hours post dose). 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 NCT01257178.

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 3 Jun 2011.

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