- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01253304
A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment
A Single Dose Pharmacokinetic Study of LY2189265 in Subjects With Varying Degrees of Hepatic Impairment
The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:
- To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function.
- To assess the safety of LY2189265 and any side effects that might be associated with it.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
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Munich, Saksa, 81241
- 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.
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Budapest, Unkari, 1032
- 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.
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
All Participants (including participants with type 2 diabetes mellitus [T2DM]):
- Male participants - Agree to use a reliable method of birth control (for example, barrier methods) during the study and for at least 3 months following dosing of study drug
Female participants:
- Women must be of non-child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause
- Women with an intact uterus are deemed postmenopausal if they are over 45 years old and have had cessation of menses for at least 1 year or have had 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) >40 international units per milliliter (IU/mL) and have not taken hormone replacement therapy or oral contraceptives within 1 year of study start and are otherwise healthy
- Women who have had cessation of menses for at least 2 years are permitted to take hormone replacement therapy
- Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
- Have venous access sufficient to allow blood sampling
- 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 Participants:
- Overtly healthy participants with normal hepatic function
- Participants with T2DM with normal hepatic function
- Have normal sitting blood pressure and pulse rate as determined by the investigator or with changes compatible with their age and disease status in case of patients with T2DM
- 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 or with changes compatible with their age and disease status in case of T2DM
Hepatic Impaired Participants:
- Have stable hepatic impairment (such as, post-alcoholic, chronic hepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh Class A, B, or C (mild, moderate, and severe impairment) who are considered by the investigator as acceptable for participation in the study. The hepatic-impaired participant population may include patients with T2DM.
- Have sitting blood pressure and pulse rate compatible with their disease state [including T2DM, if applicable] as determined by the investigator.
Participants with T2DM (All Study Groups)
- Have T2DM controlled with diet and exercise alone or T2DM is stable on a single, oral agent antihyperglycemic medication (metformin, sulfonylureas, repaglinide, nateglinide, acarbose [or other disaccharidase inhibitors], or thiazolidinediones) for at least 3 weeks (3 months for thiazolidinediones) prior to admission
- Have a glycosylated hemoglobin (HbA1C) value at screening (or within 4 weeks prior to screening) of 6.5% to 9.0%
- Have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable
- Have acceptable blood pressure and pulse rate (sitting), as determined by the investigator
Exclusion Criteria:
All participants (including participants with T2DM)
- Are currently enrolled in, discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug, 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 LY2189265 or related compounds
- Have previously completed or withdrawn from this study or any other study investigating LY2189265
- Have a current, functioning organ transplant
- Show evidence of significant active, uncontrolled, endocrine or autoimmune abnormalities (such as, thyroid disease or pernicious anemia) as judged by the screening physician
- Have shown febrile illness within 3 days prior to screening
- 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 that are not otherwise explained by permitted concomitant medications
- Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- Are women with a positive pregnancy test or women who are lactating
- Have donated blood of more than 500 milliliters (mL) within the last month prior to screening
- Have an average weekly alcohol intake that exceeds 21 units per week (men) and 14 units per week (women) (1 unit = 12 ounces [oz] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits)
- Are unwilling to stop alcohol consumption for the duration of the study (from screening until the follow-up visit)
- Are participants who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration, or are unable to abide by clinical research unit (CRU) restrictions on other inpatient days
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, (for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying [such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy] or could be aggravated by glucagon like peptide [GLP] analogs). Participants with mild hypertension and dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician.
- Are participants deemed to be unsuitable by the investigator for any reason.
Control participants:
- Have a history or presence of cardiovascular (such as, myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, renal, endocrine (with exception of participants with T2DM), hematological, neurological disorders, cancer, hepatic (including Gilbert's disease), or dermatological disorders or diseases capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Show evidence of significant active neuropsychiatric disease
- Have creatinine clearance less than 80 milliliters per minute (mL/min) (as calculated by the Cockcroft-Gault equation)
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- 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
- Prescription medication within 14 days prior to dosing participants with mild, moderate, and severe hepatic impairment
- Show evidence of any significant active disease other than that responsible for or associated with hepatic impairment. Participants with hypertension and hyperlipidemia may be permitted at the investigator's discretion.
- Show, in the opinion of the investigator, evidence of significant neuropsychiatric disease other than Grade 1 hepatic encephalopathy
- Show evidence of spontaneous bacterial peritonitis within 6 months of dosing.
- Show evidence of severe hyponatremia (Sodium [Na] <120 millimoles per liter [mmol/L])
- Show presence of hepatocellular carcinoma
- Have a portal shunt
- Show evidence of severe ascites
- Have hemoglobin <9.0 grams per deciliter (g/dL)
- Have platelet count <40 x 10^9 cells per liter (cells/L)
- Have total serum bilirubin >15 milligrams per deciliter (mg/dL)
- Use medication known to interfere with hepatic metabolism (that is, barbiturates, phenothiazines) or known to alter other major organs or systems
Mild, Hepatic Impaired Participants (Child-Pugh A)
- Show evidence of active renal disease with creatinine clearance <70 mL/min calculated by the Cockcroft-Gault equation.
- Moderate and Severe Hepatic Impaired Subjects (Child-Pugh B and C)
- Show evidence of hepatorenal syndrome as shown by creatinine clearance <50 mL/min calculated by the Cockcroft-Gault equation.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Normal hepatic function
LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
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Subcutaneous (SC) injection
Muut nimet:
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Kokeellinen: Mild hepatic impairment
LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
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Subcutaneous (SC) injection
Muut nimet:
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Kokeellinen: Moderate hepatic impairment
LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
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Subcutaneous (SC) injection
Muut nimet:
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Kokeellinen: Severe hepatic impairment
LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
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Subcutaneous (SC) injection
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Pharmacokinetics: Maximum Observed Concentration (Cmax)
Aikaikkuna: Predose to 336 hours postdose
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This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: Time of Maximum Concentration (Tmax)
Aikaikkuna: Predose to 336 hours postdose
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This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])
Aikaikkuna: Predose to 336 hours postdose
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This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])
Aikaikkuna: Predose to 336 hours postdose
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This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)
Aikaikkuna: Predose to 336 hours postdose
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The half life associated with the terminal rate constant is summarized.
This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)
Aikaikkuna: Predose to 336 hours postdose
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The apparent total body clearance of drug calculated after extra vascular administration is summarized.
This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
Aikaikkuna: Predose to 336 hours postdose
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The apparent volume of distribution during the terminal phase after extra vascular administration is summarized.
This measure was calculated using non-compartmental analysis techniques.
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Predose to 336 hours postdose
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 13765
- H9X-EW-GBDO (Muu tunniste: Eli Lilly and Company)
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