Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLBZ | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.
Part B was added to the trial in August 2013, per protocol amendment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2409021 Only (Part A, Cohort 1) | Experimental | Part A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1. |
|
| LY2409021+Gemfibrozil (Part A, Cohort 1) | Experimental | Part A, Period 2. Participants will receive a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants will also receive a single 20-mg oral dose of LY2409021 on Day 4. |
|
| LY2409021 Only (Part A, Cohort 2) | Experimental | Part A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1. |
|
| LY2409021+Ketoconazole (Part A, Cohort 2) | Experimental | Part A, Period 2. Participants will receive a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. |
|
| LY2409021+Clarithromycin (Part B) | Experimental | Part B. Participants will receive a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Evansville | Indiana | 47710 |
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted in 2 parts at a single center as an inpatient and outpatient study. Part A was an open-label, fixed sequence, 2-period, 2-cohort study. Part B was an open-label, 1-period study. Participants who completed Part A were eligible to participate in Part B.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A, Period 1. Participants received a single 20-milligram (mg) oral dose of LY2409021 on Day 1. Part A, Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28. |
| FG001 | Part A: LY2409021+Ketoconazole (Cohort 2) | Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28. |
| FG002 | Part B: LY2409021+Clarithromycin | Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A, Period 1 |
| ||||||||||||||||
| Part A, Period 2 |
| ||||||||||||||||
| Part B |
|
All participants enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: LY2409021+Gemfibrozil (Cohort 1) | Part A, Period 1. Participants received a single 20-milligram (mg) oral dose of LY2409021 on Day 1. Part A, Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28. |
| 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: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021 | All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hours per milliliter (ng*h/mL) | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2409021 Only (Part A, Cohort 1) | Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| ID | Term |
|---|---|
| C000601762 | adomeglivant |
| D015248 | Gemfibrozil |
| D007654 | Ketoconazole |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gemfibrozil | Drug |
|
| Ketoconazole | Drug |
|
| Clarithromycin | Drug |
|
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Part A: LY2409021+Ketoconazole (Cohort 2) | Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. There was a washout period from Day 22 through Day 28. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | LY2409021 Only (Part A, Cohort 2) | Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. |
| OG003 | LY2409021+Ketoconazole (Part A, Cohort 2) | Part A, Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. |
| OG004 | LY2409021 Only (Part B Participants, Data From Part A) | LY2409021 alone data are from Part A for the participants who participated in Part B. Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. |
| OG005 | LY2409021+Clarithromycin (Part B) | Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | All participants who received at least 1 dose of study drug and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only) |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| EG001 | Gemfibrozil Only (Part A, Cohort 1) | Part A, Period 2, Days -1 to 3. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-3. | 0 | 15 | 1 | 15 |
| EG002 | LY2409021+Gemfibrozil (Part A, Cohort 1) | Part A, Period 2, Day 4 to end of Period 2. Participants received a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 4-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants also received a single 20-mg oral dose of LY2409021 on Day 4. | 0 | 15 | 5 | 15 |
| EG003 | LY2409021 Only (Part A, Cohort 2) | Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1. | 0 | 15 | 5 | 15 |
| EG004 | Ketoconazole Only (Part A, Cohort 2) | Part A, Period 2, Days -1 to 3. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 1-3. | 0 | 15 | 2 | 15 |
| EG005 | LY2409021+Ketoconazole (Part A, Cohort 2) | Part A, Period 2, Day 4 to end of Period 2. Participants received a once-daily 400-mg oral dose of ketoconazole on Days 4-21 and a single 20-mg oral dose of LY2409021 on Day 4. | 0 | 15 | 9 | 15 |
| EG006 | Clarithromycin Only (Part B) | Part B, Days -1 to 3. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 1-3. | 0 | 12 | 1 | 12 |
| EG007 | LY2409021+Clarithromycin (Part B) | Part B, Day 4 to end of Part B. Participants received a twice-daily 500-mg oral dose of clarithromycin on Days 4-21 and a single 20-mg oral dose of LY2409021 on Day 4. | 0 | 12 | 8 | 12 |
| Eye irritation | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Piloerection | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |