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| ID | Type | Description | Link |
|---|---|---|---|
| I6F-MC-JJCG | Other Identifier | Eli Lilly and Company | |
| 2016-001073-33 | EudraCT Number |
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The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:
Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3039478 - Oral | Experimental | LY3039478 given once, orally |
|
| 13C 15N 2H-LY3039478 - IV | Experimental | 13C 15N 2H-LY3039478 given once, IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3039478 | Drug | Administered orally |
| |
| 13C 15N 2H-LY3039478 IV |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478 | Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478. | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
| PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478 | PK is AUC from zero to infinity (AUC[0 - inf]) of LY3039478 and 13C 15N 2H-LY3039478. | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV | PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV. | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
| PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478 |
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Inclusion Criteria:
- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive
Exclusion Criteria:
- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Leeds | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV | Simultaneous administration of a single oral dose of 75 milligram (mg) of LY3039478 and a 45-minute IV administration of 350 microgram (μg) 13C15N2H-LY3039478 in healthy participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | LY3039478 given once, orally and 13C 15N 2H-LY3039478 given once, IV. |
| 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): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478 | Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478. | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nangogram*hour/milliliter (ng*h/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
|
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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 | LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV | Simultaneous administration of a single oral dose of 75 mg of LY3039478 and a 45-minute IV administration of 350 μg 13C 15N 2H-LY3039478 in healthy participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | 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 |
|---|---|
| C000654634 | crenigacestat |
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| Drug |
Administered IV |
|
PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478. |
| Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
| PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478 | PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478. | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
| 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 |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/square meter (kg/m²) |
|
| OG001 |
| 13C 15N 2H-LY3039478 - IV |
On Day 1, 15 minutes after the 75 mg oral dose of unlabeled LY3039478, an IV infusion (duration 45 minutes) of 350 μg 13C 15N 2H-LY3039478 was started. |
|
|
| Primary | PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478 | PK is AUC from zero to infinity (AUC[0 - inf]) of LY3039478 and 13C 15N 2H-LY3039478. | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
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|
|
|
| Secondary | PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV | PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV. | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/millilter (ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
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|
|
| Secondary | PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478 | PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478. | All participants who received at least one dose of study drug. | Posted | Median | Full Range | hour (hr) | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
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|
|
| Secondary | PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478 | PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478. | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Full Range | hr | Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
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