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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBCP | Other Identifier | Eli Lilly and Company | |
| 2010-021657-39 | EudraCT Number |
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This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2189265 + Atorvastatin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Administered orally. |
| |
| LY2189265 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax) | Pre-dose to 56 hours post-dose | |
| Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC) | This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity. | Pre-dose to 56 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax) | Pre-dose to 56 hours post-dose | |
| Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Leeds | West Yorkshire | LS2 9LH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28357715 | Derived | de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Day 1 of Period 1 and Day 1 of 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Day 1 of Period 1 and Day 1 of 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax) | All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data. | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose to 56 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40 mg Atorvastatin Alone | 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 Day 1 of Period 1 and Day 1 of Period 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C555680 | dulaglutide |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Biological |
Administered subcutaneously. |
|
| Pre-dose to 56 hours post-dose |
| Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax) | Pre-dose to 56 hours post-dose |
| Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC) | This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity. | Pre-dose to 56 hours post-dose |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC) | This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity. | All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data. | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose to 56 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax) | All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data. | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose to 56 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC) | 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. | No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable. | Pre-dose to 56 hours post-dose |
|
|
| Secondary | Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax) | All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data. | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose to 56 hours post-dose |
|
|
|
| Secondary | Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC) | This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity. | All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data. | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Pre-dose to 56 hours post-dose |
|
|
|
| 0 |
| 27 |
| 8 |
| 27 |
| EG001 | 1.5 mg LY2189265 | 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. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3. | 0 | 27 | 23 | 27 |
| EG002 | 1.5 mg LY2189265 + 40 mg Atorvastatin | 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. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2. | 0 | 27 | 16 | 27 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Breath odour | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Needle track marks | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |