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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. |
|
| 1200 milligrams (mg) LY2484595 | Experimental | Administered orally once daily for 10 days during 1 of the 3 crossover periods, separated by at least a 14-day washout period. |
|
| 400 mg Moxifloxacin | Active Comparator | Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods, separated by at least a 14-day washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2484595 | Drug | Administered orally once daily for 10 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo | Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR^ß, where ß is the population correction factor. | Predose of Day 1, Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State | Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose | |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State |
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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. | Daytona Beach | Florida | 32117 |
Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; 1200 mg LY2484595, then placebo, then moxifloxacin. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Placebo or 1200 milligrams (mg) LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 1 (ABC): LY248495, then placebo, then moxifloxacin |
| FG001 | Sequence 2 | Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 2 (BCA): placebo, then moxifloxacin, then LY2484595 |
| FG002 | Sequence 3 | Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 3 (CAB): moxifloxacin, then LY2484595, placebo |
| FG003 | Sequence 4 | Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 4 (CBA): moxifloxacin, then placebo, then LY2484595 |
| FG004 | Sequence 5 | Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 5 (ACB): LY2484595, then moxifloxacin, then placebo |
| FG005 | Sequence 6 | Placebo or 1200 mg LY2484595 administered orally twice daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. Sequence 6 (BAC): placebo, then LY2484595, then moxifloxacin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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Participants received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Placebo or 1200 mg LY2484595 administered orally once daily for 10 days, or 400 mg moxifloxacin single oral dose on Day 1 during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. |
| 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 | Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo | Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR^ß, where ß is the population correction factor. | All participants who received at least one dose of study drug and had both baseline and post-baseline ECG measurements on Day 10. | Posted | Mean | Standard Deviation | milliseconds (msec) | Predose of Day 1, Day 10 |
|
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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 | LY2484595 | 1200 milligrams (mg) LY2484595 administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 14.1 | 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 |
|---|---|
| C568301 | evacetrapib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Administered orally once daily for 10 days. |
|
| Moxifloxacin | Drug | Single dose administered orally. |
|
| Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose |
| Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins | Baseline, Day 11 |
| United States |
| 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. | Evansville | Indiana | 47710 | United States |
| Did not receive treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| LY2484595 |
1200 milligrams (mg) LY2484595 administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. |
|
|
| Secondary | Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State | Participants who received at least one dose of LY2484595 and had pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State | Participants who received at least one dose of LY2484595 and had pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose |
|
|
|
| Secondary | Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins | All participants who received at least one dose of study drug and had both baseline and post-baseline lipid or apolipoprotein (Apo) measurements on Day 11. | Posted | Mean | Standard Deviation | percentage change | Baseline, Day 11 |
|
|
|
| 0 |
| 70 |
| 33 |
| 70 |
| EG001 | Placebo | Administered orally once daily for 10 days during 1 of the 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. | 1 | 69 | 24 | 69 |
| EG002 | Moxifloxacin | 400 mg Moxifloxacin: Positive control, unblinded treatment administered orally once during 1 of 3 crossover periods. There was at least 14 days washout between consecutive dosing periods. | 0 | 69 | 11 | 69 |
| Ear pruritus | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Application site rash | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Eye injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dysaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Bladder dilatation | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Low-density lipoprotein cholesterol (LDL-C) |
|
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| Apo-A1 |
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| Apo-B |
|
|