Pharmacokinetics: Maximum Observed Concentration (Cmax)
| Group | Value (nanograms/milliliter (ng/mL)) | Spread |
|---|---|---|
| Normal Hepatic Function | 84.5 | 29 |
| Mild Hepatic Impairment | 63.0 | 30 |
| Moderate Hepatic Impairment | 58.1 | 28 |
| Severe Hepatic Impairment | 61.3 | 18 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataGermany, Hungary
1 trial · 1 completed · 1 with posted results
A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment
NCT01253304Nov 2010 to Nov 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Normal hepatic function
LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
Experimental
Mild hepatic impairment
LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
Experimental
Moderate hepatic impairment
LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
Experimental
Severe hepatic impairment
LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
Outcomes the sponsor listed as primary.
Pharmacokinetics: Maximum Observed Concentration (Cmax)
Time frame · Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Time of Maximum Concentration (Tmax)
Time frame · Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])
Time frame · Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])
Time frame · Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)
Time frame · Predose to 336 hours postdose
The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)
Time frame · Predose to 336 hours postdose
The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
Time frame · Predose to 336 hours postdose
The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nanograms/milliliter (ng/mL)) | Spread |
|---|---|---|
| Normal Hepatic Function | 84.5 | 29 |
| Mild Hepatic Impairment | 63.0 | 30 |
| Moderate Hepatic Impairment | 58.1 | 28 |
| Severe Hepatic Impairment | 61.3 | 18 |
| Group | Value (hours) |
|---|---|
| Normal Hepatic Function | 48.00 |
| Mild Hepatic Impairment | 48.01 |
| Moderate Hepatic Impairment | 59.96 |
| Severe Hepatic Impairment | 71.93 |
| Group | Value (nanograms times hour/milliliter(ng*hr/mL) | Spread |
|---|---|---|
| Normal Hepatic Function | 10200 | 26 |
| Mild Hepatic Impairment | 7670 | 27 |
| Moderate Hepatic Impairment | 7220 | 19 |
| Severe Hepatic Impairment | 7660 | 13 |
| Group | Value (nanograms times hr/milliliter (ng*hr/mL)) | Spread |
|---|---|---|
| Normal Hepatic Function | 16300 | 24 |
| Mild Hepatic Impairment | 12200 | 26 |
| Moderate Hepatic Impairment | 11200 | 14 |
| Severe Hepatic Impairment | 12500 | 5 |
| Group | Value (hours) |
|---|---|
| Normal Hepatic Function | 104 |
| Mild Hepatic Impairment | 101 |
| Moderate Hepatic Impairment | 88.2 |
| Severe Hepatic Impairment | 99.2 |
| Group | Value (liters/hour (L/h)) | Spread |
|---|---|---|
| Normal Hepatic Function | 0.0920 | 24 |
| Mild Hepatic Impairment | 0.123 | 26 |
| Moderate Hepatic Impairment | 0.135 | 14 |
| Severe Hepatic Impairment | 0.120 | 5 |
| Group | Value (liters (L)) | Spread |
|---|---|---|
| Normal Hepatic Function | 13.8 | 27 |
| Mild Hepatic Impairment | 17.9 | 27 |
| Moderate Hepatic Impairment | 17.1 | 20 |
| Severe Hepatic Impairment | 17.1 | 24 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Normal Hepatic FunctionLY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function | – | 0 / 11 | 10 / 11 |
| Mild Hepatic ImpairmentLY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) | – | 0 / 6 | 5 / 6 |
| Moderate Hepatic ImpairmentLY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) | – | 1 / 6 | 5 / 6 |
| Severe Hepatic ImpairmentLY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) | – | 1 / 3 | 1 / 3 |
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