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| ID | Type | Description | Link |
|---|---|---|---|
| I6B-MC-HZBA | Other Identifier | Eli Lilly and Company |
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Study terminated due to unacceptable pharmacokinetic (PK) profile.
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The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.
This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.
This study has two parts:
Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).
Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning. |
|
| LY3006072 | Experimental | Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Capsules administered orally |
| |
| LY3006072 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module. | Baseline, up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose | |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072. |
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Inclusion 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. | Evansville | Indiana | 47710 |
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This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Sequence 1) | Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo |
| FG001 | Cohort 1 (Sequence 2) | Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072 |
| FG002 | Cohort 1 Sequence 3 | Participants received LY3006072 and Placebo capsules as per below dosing schedule. Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 |
| FG003 | Cohort 1 Sequence 4 | Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule. Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 |
| FG004 | Cohort 2 (Sequence 1) | Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072 |
| FG005 | Cohort 2 (Sequence 2) | Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072 |
| FG006 | Cohort 2 (Sequence 3) | Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
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| Period 3 |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Sequence 1) | Participants received LY3006072 and Placebo capsules as per below dosing schedules. Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo |
| BG001 | Cohort 1 (Sequence 2) |
| 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 | Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs | AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline, up to 21 days |
|
Up To 21 Days
All randomized participants who received at least one 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 | Placebo | Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
Part B was not initiated as study was terminated early due to technical factors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Drug |
Capsules administered orally |
|
| Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
| BG002 | Cohort 1 (Sequence 3) | Participants received LY3006072 and Placebo capsules as per below dosing schedule. Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 |
| BG003 | Cohort 1 (Sequence 4) | Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule. Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072 |
| BG004 | Cohort 2 (Sequence 1) | Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: Placebo and Period 2: 20 mg LY3006072 |
| BG005 | Cohort 2 (Sequence 2) | Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072 |
| BG006 | Cohort 2 (Sequence 3) | Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule. Period 1: 3 mg LY3006072 and Period 2: Placebo |
| BG007 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
| OG002 | 3 mg LY3006072 | Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. |
| OG003 | 10 mg LY3006072 | Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. |
| OG004 | 20 mg LY3006072 | Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. |
| OG005 | 40 mg LY3006072 | Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. |
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072 | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072 | PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072. | All randomized participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hours per mL (ng*hr/mL) | Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 1 mg LY3006072 | Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. | 0 | 6 | 3 | 6 |
| EG002 | 3 mg LY3006072 | Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. | 0 | 6 | 1 | 6 |
| EG003 | 10 mg LY3006072 | Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. | 0 | 6 | 1 | 6 |
| EG004 | 20 mg LY3006072 | Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. | 0 | 6 | 2 | 6 |
| EG005 | 40 mg LY3006072 | Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning. | 0 | 6 | 6 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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