Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
| Group | Value (nanograms*hour/milliliter/milligram) |
|---|---|
| Part B: LY2189265 Subcutaneous | 10256 |
| Part B: LY2189265 Intravenous | 23150 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.
NCT01301092Feb 2011 to Aug 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above. The study is divided into three parts, Part A, B and C. Volunteers will only be able to participate in one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of the study will occur after Part A because the dose of IV drug will depend on the results of Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the drug. Participants in Part C will also be given drug twice by an SC injection and an IM injection, both doses will be 0.75 mg.
Experimental
Part A: LY2189265 intravenous
Single intravenous (IV) dose, starting at 0.1 milligrams (mg) of LY2189265. Dose may be increased to 0.2 mg or decreased to 0.05 mg for subsequent patients, dependent on safety assessments of the first 3 patients.
Experimental
Part B: LY2189265 subcutaneous, intravenous
Patients are randomized to 2 sequences of 2 treatments. Single 1.5 mg subcutaneous (SC) dose of LY2189265 in Period 1; single intravenous (IV) dose of LY2189265 (determined by Part A IV arm data) in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.
Experimental
Part C: LY2189265 subcutaneous, intramuscular
Patients are randomized to 2 sequences of 2 treatments. Single 0.75 mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75 mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.
Outcomes the sponsor listed as primary.
Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Time frame · Predose up to 336 hours postdose
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Time frame · Predose up to 336 hours postdose
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Time frame · Predose up to 336 hours postdose
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Time frame · Predose up to 336 hours postdose
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nanograms*hour/milliliter/milligram) |
|---|---|
| Part B: LY2189265 Subcutaneous | 10256 |
| Part B: LY2189265 Intravenous | 23150 |
| Group | Value (nanograms/milliliter (ng/mL)) |
|---|---|
| Part B: LY2189265 Subcutaneous | 80.7 |
| Part B: LY2189265 Intravenous | 38.3 |
| Group | Value (nanograms*hour/milliliter (ng*h/mL)) |
|---|---|
| Part C: LY2189265 Intramuscular | 9828 |
| Part C: LY2189265 Subcutaneous | 10215 |
| Group | Value (nanograms/milliliter (ng/mL)) |
|---|---|
| Part C: LY2189265 Intramuscular | 56.9 |
| Part C: LY2189265 Subcutaneous | 54.2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part A: 0.1 mg IV LY2189265Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265 | – | 0 / 6 | 0 / 6 |
| Part B: 0.1 mg IV LY2189265Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2. | – | 0 / 16 | 7 / 16 |
| Part B: 1.5 mg SC LY2189265Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. | – | 0 / 16 | 9 / 16 |
| Part C: 0.75 mg IM LY2189265Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2. | – | 0 / 8 | 3 / 8 |
| Part C: 0.75 mg SC LY2189265Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. | – | 0 / 8 | 2 / 8 |
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