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| ID | Type | Description | Link |
|---|---|---|---|
| I7T-MC-RMAG | Other Identifier | Eli Lilly and Company |
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The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.
The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.
The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.
There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2623091 (Group 1) | Experimental | LY2623091 administered orally once on Day 1 of Period 1. |
|
| Itraconazole + LY2623091 (Group 1) | Experimental | 200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2. |
|
| Simvastatin (Group 2) | Experimental | 20 mg simvastatin administered orally once daily on Day 1. |
|
| LY2623091 + Simvastatin (Group 2) | Experimental | LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12. |
|
| Tadalafil (Group 3) | Experimental | 5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2623091 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091 | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose | |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091 | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose | |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose | |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose | |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose | |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
This study planned to enroll 3 groups. After Groups 1 and 2 were enrolled, data from Group 2 were analyzed according to a pre-specified algorithm. Results met criteria to enroll Group 4. (Group 3 was not enrolled.)
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2623091 + Itraconazole (Group 1) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. |
| FG001 | Simvastatin + LY2623091 (Group 2) | Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. |
| FG002 | LY2623091 + Diltiazem (Group 4) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||||||||
| Period 2 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2623091 + Itraconazole (Group 1) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6. |
| BG001 | Simvastatin + LY2623091 (Group 2) |
| 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: Maximum Drug Concentration (Cmax) of LY2623091 | All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable Cmax results. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
|
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Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
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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 | LY2623091 (Group 1) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA 17.1 | 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 |
|---|---|
| D017964 | Itraconazole |
| D019821 | Simvastatin |
| D000068581 | Tadalafil |
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Tadalafil + LY2623091 (Group 3) |
| Experimental |
LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
|
| LY2623091 (Group 4) | Experimental | LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2. |
|
| Diltiazem + LY2623091 (Group 4) | Experimental | 240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2. |
|
| Itraconazole | Drug | Administered orally |
|
| Simvastatin | Drug | Administered orally |
|
| Tadalafil | Drug | Administered orally |
|
| Diltiazem | Drug | Administered orally |
|
| NOT COMPLETED |
|
|
Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12. |
| BG002 | LY2623091 + Diltiazem (Group 4) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| OG002 | LY2623091 (Group 4) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. . |
| OG003 | Diltiazem + LY2623091 (Group 4) | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4. |
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091 | All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-infinity) results. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 | All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-tlast) results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose |
|
|
|
| Primary | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid | All participants in Group 2 who received at least one dose of study drug and had evaluable Cmax results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid | All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-infinity) results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid | All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-tlast) results. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Itraconazole (Group 1) | Period 2: Oral doses of 200 mg itraconazole BID on Days 1 through 5. | 0 | 16 | 3 | 16 |
| EG002 | Itraconazole + LY2623091 (Group 1) | Period 2: Oral doses of 200 mg itraconazole and 6 mg LY2623091 coadministered once on Day 6. | 0 | 16 | 6 | 16 |
| EG003 | Simvastatin (Group 2) | Single oral dose of 20 mg simvastatin on Day 1. | 0 | 16 | 0 | 16 |
| EG004 | LY2623091 (Group 2) | Oral doses of 24.5 mg LY2623091 QD on Days 3 to 11. | 0 | 16 | 4 | 16 |
| EG005 | LY2623091 + Simvastatin (Group 2) | Oral doses of 24.5 mg LY2623091 and 20 mg simvastatin coadministered once on Day 12. | 0 | 16 | 1 | 16 |
| EG006 | LY2623091 (Group 4) | Period 1: Single oral dose of 6 mg LY2623091 on Day 1. | 0 | 16 | 3 | 16 |
| EG007 | Diltiazem (Group 4) | Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 through 3. | 0 | 14 | 1 | 14 |
| EG008 | Diltiazem + LY2623091 (Group 4) | Period 2: Oral doses of 240 mg diltiazem extended release and 6 mg LY2623091 coadministered once on Day 4. | 0 | 14 | 1 | 14 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
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| D010879 |
| Piperazines |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001552 | Benzazepines |
| Simvastatin Acid |
|
|