Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)
| Group | Value (nanogram per milliliter (ng/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 19.5 | 60 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 5.78 | 86 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.
Experimental
LY2189265 + Atorvastatin
Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Period 1 and Period 2. Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
Outcomes the sponsor listed as primary.
Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)
Time frame · Pre-dose to 56 hours post-dose
Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)
Time frame · Pre-dose to 56 hours post-dose
This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.
Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Time frame · Pre-dose to 56 hours post-dose
Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)
Time frame · Pre-dose to 56 hours post-dose
This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)
Time frame · Pre-dose to 56 hours post-dose
Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)
Time frame · Pre-dose to 56 hours post-dose
This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nanogram per milliliter (ng/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 19.5 | 60 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 5.78 | 86 |
| Group | Value (nanogram*hour per milliliter (ng*h/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 82.8 | 33 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 65.9 | 35 |
| Group | Value (nanogram per milliliter (ng/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 0.473 | 81 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 0.360 | 69 |
| Group | Value |
|---|---|
| 40 mg Atorvastatin Alone | not posted |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | not posted |
| Group | Value (nanogram per milliliter (ng/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 14.4 | 46 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 5.66 | 60 |
| Group | Value (nanogram*hour per milliliter (ng*h/mL)) | Spread |
|---|---|---|
| 40 mg Atorvastatin Alone | 102 | 30 |
| 1.5 mg LY2189265 + 40 mg Atorvastatin | 95.9 | 28 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 40 mg Atorvastatin AlonePeriod 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2. | – | 0 / 27 | 8 / 27 |
| 1.5 mg LY2189265Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3. | – | 0 / 27 | 23 / 27 |
| 1.5 mg LY2189265 + 40 mg AtorvastatinPeriod 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2. | – | 0 / 27 | 16 / 27 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2017
de la Peña et al. 2017Clinical pharmacokineticscited by 22
PMID 28357715DOI 10.1007/s40262-017-0531-7PUB-28357715
Who could join, as posted.
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