Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril
| Group | Value ((nanograms*hours/milliliter)/milligram) | Spread |
|---|---|---|
| Part 1: LY2189265 + Lisinopril | 1580 | 55 |
| Part 1: Placebo + Lisinopril | 1740 | 26 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is twofold: 1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril. 2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers when taken with a Beta-blocker drug (metoprolol). In Part 1, participants will receive four weekly injections of LY2189265 with continued use of normal lisinopril therapy. Part 2 is a cross-over study design. Participants will receive a single injection of LY2189265 in one period, and seven daily doses of metoprolol and a single injection of LY2189265 in another period.
Experimental
LY2189265 + Lisinopril
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
Placebo comparator
Placebo + Lisinopril
Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
Experimental
LY2189265 (Treatment 1)/Metoprolol + LY2189265 (Treatment 2)
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study. Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study. There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study).
Experimental
Metoprolol + LY2189265 (Treatment 2)/LY2189265 (Treatment 1)
LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study. Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study. There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study).
Outcomes the sponsor listed as primary.
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril
Time frame · Day -1, Day 3, Day 24 of Part 1
Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril
Time frame · Day -1, Day 3, Day 24 in Part 1
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Time frame · Day -1, Day 4, Day 7 of Treatment 2 in Part 2
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol
Time frame · Day -1, Day 4, Day 7 of Treatment 2 in Part 2
Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Time frame · Day -1, Day 3, Day 24 of Part 1
Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril
Time frame · Day -1, Day 3, Day 24 of Part 1
Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265
Time frame · Day 4 and Day 7 of Treatment 2 in Part 2
Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265
Time frame · Day 4 and Day 7 of Treatment 2 in Part 2
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value ((nanograms*hours/milliliter)/milligram) | Spread |
|---|---|---|
| Part 1: LY2189265 + Lisinopril | 1580 | 55 |
| Part 1: Placebo + Lisinopril | 1740 | 26 |
| Group | Value ((nanograms per milliliter) per milligram) | Spread |
|---|---|---|
| Part 1: LY2189265 + Lisinopril | 122 | 56 |
| Part 1: Placebo + Lisinopril | 138 | 22 |
| Group | Value (beats per minute (bpm)) | Spread |
|---|---|---|
| Part 2: LY2189265 + Metoprolol (Treatment 2) | 63.7 | 9.6 |
| Group | Value (millimeter of mercury (mm Hg)) | Spread |
|---|---|---|
| Part 2: LY2189265 + Metoprolol (Treatment 2) | 123.0 | 11.4 |
| Group | Value (beats per minute (bpm)) | Spread |
|---|---|---|
| Part 1: LY2189265 + Lisinopril | 69.8 | 8.9 |
| Part 1: Placebo + Lisinopril | 68.9 | 6.6 |
| Group | Value (millimeter of mercury (mm Hg)) | Spread |
|---|---|---|
| Part 1: LY2189265 + Lisinopril | 129.4 | 14.1 |
| Part 1: Placebo + Lisinopril | 130.1 | 14.9 |
| Group | Value (nanograms*hour per milliliter (ng*h/mL)) | Spread |
|---|---|---|
| Part 2: LY2189265 + Metoprolol Crossover | 617 | 69 |
| Group | Value (nanograms per milliliter (ng/mL)) | Spread |
|---|---|---|
| Part 2: LY2189265 + Metoprolol Crossover | 35.7 | 63 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part 1: LY2189265 + LisinoprilLY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study. | – | 0 / 23 | 13 / 23 |
| Part 1: Placebo + LisinoprilPlacebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study. | – | 0 / 8 | 1 / 8 |
| Part 2: LY2189265LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study. Time frame: Treatment 1 | – | 0 / 19 | 7 / 19 |
| Part 2: MetoprololMetoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study. Time frame: Days 1 to 4 of Treatment 2 | – | 0 / 20 | 4 / 20 |
| Part 2: LY2189265 + MetoprololLY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study. Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study. Time frame: Day 5 to end of Treatment 2 | – | 0 / 19 | 13 / 19 |
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