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| ID | Type | Description | Link |
|---|---|---|---|
| H8H-MC-LAIO | Other Identifier | Eli Lilly and Company |
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The main purpose of the study is to investigate the blood concentrations of dabigatran etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin in combination with lasmiditan will also be evaluated in healthy participants. The study has two parts. Each part will last up to 17 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 Milligram (mg) Dabigatran Etexilate + 200mg Lasmiditan - Part 1 | Experimental | Participants received 150 mg dabigatran etexilate on Day 1 followed by 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally |
|
| 10 mg Rosuvastatin + 200 mg Lasmiditan - Part 2 | Experimental | Participants received 10 mg rosuvastatin on Day 1 followed by 200 mg lasmiditan QD on Days 8 and 9, and 10 mg of rosuvastatin along with 200 mg lasmiditan on Day 10. All treatments were administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lasmiditan | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran to Assess P-glycoprotein (P-gp) Activity. | PK: Cmax of Dabigatran. | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. |
| Part 2 PK: Cmax of Rosuvastatin to Assess Breast Cancer Resistance Protein (BCRP) Activity. | PK: Cmax of Rosuvastatin. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose. |
| Part 1 PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] ) of Dabigatran to Assess P-gp Activity. | PK: AUC[0-∞] of Dabigatran | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. |
| Part 2 PK: AUC[0-∞] of Rosuvastatin to Assess BCRP Activity. | PK: AUC[0-∞] of Rosuvastatin | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose. |
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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This study consisted of two parts - Part 1 and Part 2, each consisting of two periods. Part 1 studied dabigatran P-glycoprotein (P-gp) drug-drug interaction with lasmiditan. Part 2 studied rosuvastatin breast cancer resistance protein (BCRP) drug-drug interaction with lasmiditan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 Milligram (mg) Dabigatran Etexilate-Part 1 Period 1 | Participants received a single oral dose 150 mg dabigatran etexilate on Day 1. |
| FG001 | 150 mg Dabigatran Etexilate + 200 mg Lasmiditan-Part 1 Period 2 | After Period 1, participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. |
| FG002 | 10 mg Rosuvastatin-Part 2 Period 1 | Participants received a single oral dose of 10 mg rosuvastatin on Day 1. |
| FG003 | 10 mg Rosuvastatin + 200 mg Lasmiditan-Part 2 Period 2 | After Period 1, participants received 200 mg lasmiditan QD on Days 8 and 9, and then received 10 mg rosuvastatin along with 200 mg lasmiditan on Day 10. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 150 mg Dabigatran Etexilate-Part 1 Period 1 | Participants received a single oral dose 150 mg dabigatran etexilate on Day 1. |
| BG001 | 10 mg Rosuvastatin-Part 2 Period 1 | Participants received a single oral dose of 10 mg rosuvastatin on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Part 1 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran to Assess P-glycoprotein (P-gp) Activity. | PK: Cmax of Dabigatran. | All participants from Part 1 who received at least 1 dose of Dabigatran etexilate and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. |
|
Baseline up to follow up visit, an average of 17 days.
All participants who received at least 1 dose of study drug.
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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 | 150 Milligram (mg) Dabigatran Etexilate (Part 1 Period 1) | Participants received a single oral dose 150 mg dabigatran etexilate on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2020 | Jun 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 3, 2020 | Jun 23, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C554777 | lasmiditan |
| D000069604 | Dabigatran |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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|
| Dabigatran Etexilate | Drug | Administered orally. |
|
| Rosuvastatin | Drug | Administered orally. |
|
| Withdrawal by Subject |
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 200 mg lasmiditan once daily (QD) on Days 8 and 9, and 150 mg of dabigatran etexilate along with 200 mg lasmiditan on Day 10. All treatments were administered orally.
|
|
| Primary | Part 2 PK: Cmax of Rosuvastatin to Assess Breast Cancer Resistance Protein (BCRP) Activity. | PK: Cmax of Rosuvastatin. | All participants from Part 2 who received at least 1 dose of Rosuvastatin and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose. |
|
|
|
| Primary | Part 1 PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] ) of Dabigatran to Assess P-gp Activity. | PK: AUC[0-∞] of Dabigatran | All participants from Part 1 who received at least 1 dose of Dabigatran etexilate had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. |
|
|
|
| Primary | Part 2 PK: AUC[0-∞] of Rosuvastatin to Assess BCRP Activity. | PK: AUC[0-∞] of Rosuvastatin | All participants from Part 2 who received at least 1 dose of Rosuvastatin and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 hours post-dose. |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 14 |
| 66 |
| EG001 | 200 mg Lasmiditan (Part 1 Period 2) | After Part 1 Period 1, participants received oral doses of 200 mg lasmiditan once daily (QD) on Days 8 and 9. | 0 | 64 | 0 | 64 | 44 | 64 |
| EG002 | 150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2) | Following lasmiditan administration on Days 8 and 9, participants received 150 mg dabigatran etexilate + 200 mg lasmiditan administered orally on Day 10. | 0 | 64 | 0 | 64 | 30 | 64 |
| EG003 | 10 mg Rosuvastatin (Part 2 Period 1) | Participants received a single oral dose of 10 mg rosuvastatin on Day 1. | 0 | 30 | 0 | 30 | 6 | 30 |
| EG004 | 200 mg Lasmiditan (Part 2 Period 2) | After Part 2 Period 1, participants received oral doses of 200 mg lasmiditan QD on Days 8 and 9. | 0 | 30 | 0 | 30 | 17 | 30 |
| EG005 | 10 mg Rosuvastatin + 200 mg Lasmiditan (Part 2 Period 2) | Following lasmiditan administration on Days 8 and 9, participants received 10 mg rosuvastatin + 200 mg lasmiditan administered orally on Day 10. | 0 | 30 | 0 | 30 | 9 | 30 |
| Catheter site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |