Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I6H-MC-MCBB | 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
This is a study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream and how long it takes the body to remove the study drug. The effects of LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any side effects that occur will be collected. The study is expected to last 21 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo matching LY3023703 administered orally, once daily (QD), for 28 days |
|
| LY3023703 | Experimental | Escalating doses (2.5 milligram [mg] up to 30 mg) of LY3023703 administered orally, QD, for 28 days |
|
| Celecoxib | Active Comparator | 400 mg celecoxib administered orally, QD, for 28 days. (Positive control.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| LY3023703 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module. | Baseline to Study Completion (up to 74 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703 | Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703 |
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
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered by mouth (PO), once a day (QD), for 28 days |
| FG001 | 2.5 mg LY3023703 | 2.5 milligram (mg) LY3023703 administered PO, QD, for 28 days |
| FG002 | 7.5 mg LY3023703 | 7.5 mg LY3023703 administered PO, QD, for 28 days |
| FG003 | 15 mg LY3023703 | 15 mg LY3023703 administered PO, QD, for 28 days |
| FG004 | 30 mg LY3023703 | 30 mg LY3023703 administered PO, QD, for 28 days |
| FG005 | 400 mg Celecoxib | 400 mg celecoxib administered PO, QD, for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered PO, QD, for 28 days |
| BG001 | 2.5 mg LY3023703 | 2.5 mg LY3023703 administered PO, QD, for 28 days |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module. | Randomized participants who reported an AE that met any of the serious criteria. | Posted | Count of Participants | Participants | No | Baseline to Study Completion (up to 74 Days) |
|
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 | Placebo | Placebo administered PO, QD, for 28 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered orally |
|
| Celecoxib | Drug | Administered orally |
|
| Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) |
| Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703 | Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) |
| Change From Baseline to Day 27 in Blood Pressure (BP) | The Day 27 change from Day -1 was analyzed by using analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline Day -1 as a covariate. The treatment mean, difference to placebo, and difference to celecoxib were output with corresponding 90% confidence intervals. | Baseline, Day 27 |
| United States |
| BG002 | 7.5 mg LY3023703 | 7.5 mg LY3023703 administered PO, QD, for 28 days |
| BG003 | 15 mg LY3023703 | 15 mg LY3023703 administered PO, QD, for 28 days |
| BG004 | 30 mg LY3023703 | 30 mg LY3023703 administered PO, QD, for 28 days |
| BG005 | 400 mg Celecoxib | 400 mg celecoxib administered PO, QD, for 28 days |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | 7.5 mg LY3023703 | 7.5 mg LY3023703 administered PO, QD, for 28 days |
| OG003 | 15 mg LY3023703 | 15 mg LY3023703 administered PO, QD, for 28 days |
| OG004 | 30 mg LY3023703 | 30 mg LY3023703 administered PO, QD, for 28 days |
| OG005 | 400 mg Celecoxib | 400 mg celecoxib administered PO, QD, for 28 days |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703 | All randomized participants who received at least one dose of the study medication and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours•nanogram/milliliter (hr•ng/mL) | Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703 | All randomized participants who received at least one dose of the study medication and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) |
|
|
|
| Secondary | Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703 | All randomly assigned participants who received at least one dose of the study medication and had evaluable PK data. | Posted | Median | Full Range | Hours | Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) |
|
|
|
| Secondary | Change From Baseline to Day 27 in Blood Pressure (BP) | The Day 27 change from Day -1 was analyzed by using analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline Day -1 as a covariate. The treatment mean, difference to placebo, and difference to celecoxib were output with corresponding 90% confidence intervals. | All randomized participants who received at least one dose of study treatment and had evaluable data. | Posted | Least Squares Mean | 90% Confidence Interval | millimeters of mercury (mmHg) | Baseline, Day 27 |
|
|
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | 2.5 mg LY3023703 | 2.5 mg LY3023703 administered PO, QD, for 28 days | 0 | 8 | 3 | 8 |
| EG002 | 7.5 mg LY3023703 | 7.5 mg LY3023703 administered PO, QD, for 28 days | 0 | 8 | 3 | 8 |
| EG003 | 15 mg LY3023703 | 15 mg LY3023703 administered PO, QD, for 28 days | 0 | 8 | 4 | 8 |
| EG004 | 30 mg LY3023703 | 30 mg LY3023703 administered PO, QD, for 28 days | 0 | 8 | 5 | 8 |
| EG005 | 400 mg Celecoxib | 400 mg celecoxib administered PO, QD, for 28 days | 0 | 8 | 3 | 8 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood immunoglobulin e increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| Multiple Oral Doses (Day 28) |
|
|
|
| Multiple Oral Doses (Day 28) |
|
|
|
| Multiple Oral Doses (Day 28) |
|
|
| Diastolic Blood Pressure (DBP) |
|
| Mean Difference (Final Values) |
| -1.09 |
| 2-Sided |
| 90 |
| -4.70 |
| 2.53 |
| Superiority |
| SBP | Mean Difference (Final Values) | -1.54 | 2-Sided | 90 | -5.30 | 2.22 | Superiority |
| SBP | Mean Difference (Final Values) | -1.53 | 2-Sided | 90 | -5.16 | 2.10 | Superiority |
| SBP | Mean Difference (Final Values) | -3.84 | 2-Sided | 90 | -7.74 | 0.07 | Superiority |
| DBP | Mean Difference (Final Values) | -0.38 | 2-Sided | 90 | -2.95 | 2.18 | Superiority |
| DBP | Mean Difference (Final Values) | -1.11 | 2-Sided | 90 | -3.69 | 1.48 | Superiority |
| DBP | Mean Difference (Final Values) | -0.95 | 2-Sided | 90 | -3.75 | 1.85 | Superiority |
| DBP | Mean Difference (Final Values) | -1.49 | 2-Sided | 90 | -4.09 | 1.10 | Superiority |
| DBP | Mean Difference (Final Values) | -2.51 | 2-Sided | 90 | -5.23 | 0.20 | Superiority |