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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBCR | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected.
This study is for research purposes only and is not intended to treat any medical condition. This research study requires that a blood sample be obtained and stored for future research involving genetic analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin + Dulaglutide | Experimental | Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Administered orally |
| |
| Dulaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 | |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 | |
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 |
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Inclusion Criteria:
Are overtly healthy males or females, as determined by medical history and physical examination
Male participants with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following:
Female participants not of child-bearing potential (that is, they are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrolment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL)
Female participants who have undergone sterilization by tubal ligation agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrolment
Have a body mass index (BMI) of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive, at screening
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator (potassium, magnesium, and calcium values must be within the normal range)
Have normal renal function defined as an estimated creatinine clearance (CrCl) of ≥80 milliliter per minute (mL/min)
Have venous access sufficient to allow for blood sampling
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28357715 | Derived | de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digoxin + Dulaglutide | Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digoxin + Dulaglutide | Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. |
| 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 Versus Time Curve (AUC) of Digoxin | Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data. | Geometric Mean | Geometric Coefficient of Variation | nanograms times hours/milliliter | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 |
|
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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 | Digoxin | Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 14.0 | 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 |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| C555680 | dulaglutide |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Biological |
Administered as subcutaneous injection |
|
|
| United States |
| 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 |
|
|
|
| Primary | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin | Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data. | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 |
|
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data. | Median | Full Range | hours | Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17 |
|
|
|
| 0 |
| 24 |
| 13 |
| 24 |
| EG001 | Digoxin + Dulaglutide | Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. | 0 | 21 | 16 | 21 |
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Day 17 (n=20) |
|
| Day 17 (n=20) |
|