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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLBT | Other Identifier | Eli Lilly and Company |
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The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function. There were five study groups. Each participant only enrolled in one group. Participants in groups 1 through 4 were healthy or have mild, moderate, or severe kidney disease. They completed one study period lasting about 29 days. Study group 5 enrolled participants with kidney disease who were on dialysis. They have completed two study periods which together last about 59 days. Screening was required within 21 days prior to the start of the study for all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2409021 Control | Experimental | Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
|
| LY2409021 Mild Renal Impairment | Experimental | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
|
| LY2409021 Moderate Renal Impairment | Experimental | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
|
| LY2409021 Severe Renal Impairment | Experimental | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
|
| LY2409021 End Stage Renal Disease | Experimental | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 | Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose | |
| Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021 | Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis | Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose | |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis |
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Inclusion Criteria:
Inclusion Criteria for ALL Participants
Additional Inclusion Criteria for Control (Healthy) Participants
- Control participants must have normal renal function, assessed by mean estimated creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min) at screening and day before dosing
Additional Inclusion Criteria for Participants with Mild-to-Severe Renal Impairment or End Stage Renal Disease (ESRD)
- Males or females with stable mild-to-severe renal impairment, assessed by estimated CLcr, or with ESRD requiring hemodialysis (or hemodiafiltration) for at least 3 months
Additional Inclusion Criteria for Participants with Type 2 Diabetes Mellitus (T2DM)
- Participants with T2DM that are being treated with diet or exercise alone or receive treatment with insulin
Exclusion Criteria:
Exclusion Criteria for ALL Participants
Additional Exclusion Criteria for Participants with Mild, Moderate or Severe Renal Impairment or ESRD:
Additional Exclusion Criteria for Participants with T2DM:
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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. | Munich | 81241 |
This study consisted of 5 groups: Group 1-4 (Normal Renal Function Control, Mild, Moderate and Severe Renal Impairment) and Group 5 [End-stage Renal Disease (ESRD)].
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2409021 Control | Healthy participants received a single 80 milligram (mg) dose of LY2409021 orally on Day 1 of the study. |
| FG001 | LY2409021 Mild Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| FG002 | LY2409021 Moderate Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| FG003 | LY2409021 Severe Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| FG004 | LY2409021 End Stage Renal Disease | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1(Dialysis) of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 (Non Dialysis) of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (All Groups) |
|
| ||||||||||||||||||
| Period 2 (End Stage Renal Disease Only) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2409021 Control | Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| BG001 | LY2409021 Mild Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| 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 (PK): Maximum Concentration (Cmax) of LY2409021 | All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
|
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One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
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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 | LY2409021 Control | Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
One participant who received drug was identified as deviating from the protocol due to having Type 1 Diabetes Mellitus (T1DM) and was discontinued and data are not included in Baseline Characteristics, Outcome Measures or AEs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
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| Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
| Germany |
| 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. | Liverpool | L7 8XP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | LY2409021 Moderate Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| BG003 | LY2409021 Severe Renal Impairment | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study. |
| BG004 | LY2409021 End Stage Renal Disease | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type 2 Diabetes Mellitus (T2DM) status | Count of Participants | Participants | No |
|
| Creatinine clearance (CLcr) | Calculated using the mean of screening and Day -1 values for each individual participant. | Mean | Standard Deviation | mL/min |
|
| Estimated Glomerular Filtration Rate (eGRF) | Calculated using Day -1 values for each individual participant. | Mean | Standard Deviation | mL/min/1.73m² |
|
| OG002 | LY2409021 Moderate Renal Impairment | Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study |
| OG003 | LY2409021 Severe Renal Impairment | Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021 | All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram x hour per milliliter(ng•h/mL) | Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis | All participants in Group 5 who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis | All participants in Group 5 who received at least 1 dose of study drug and had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng•h/mL | Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose |
|
|
|
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | LY2409021 Mild Renal Impairment | Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study. | 0 | 8 | 4 | 8 |
| EG002 | LY2409021 Moderate Renal Impairment | Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study. | 0 | 8 | 3 | 8 |
| EG003 | LY2409021 Severe Renal Impairment | Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study. | 0 | 8 | 6 | 8 |
| EG004 | LY2409021 End Stage Renal Disease | Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study. | 0 | 8 | 5 | 8 |
| Eye irritation | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Nail injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Procedural site reaction | 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 |
|
| Blood phosphorus decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |