Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8K-JE-JPDB | 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
The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3337641 Multiple Dose | Experimental | Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period. |
|
| Placebo Multiple Dose | Placebo Comparator | Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period. |
|
| LY3337641 Single Dose | Experimental | Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period. |
|
| Placebo Single Dose | Placebo Comparator | Single dose of placebo administered orally, with a two week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3337641 | Drug | Administered orally. |
| |
| 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 | Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Up To 31 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641 | Cmax of LY3337641 was evaluated. | MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose |
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 |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States |
The study consisted of multiple-doses (MD) in Cohort 1 and single-dose (SD) for Cohorts 2, 3, and 4.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo SD | Participants received single oral dose of placebo tablet with a two week follow-up period. |
| FG001 | 5 mg LY3337641 SD | Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period. |
| FG002 | 80 mg LY3337641 SD | Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period. |
| FG003 | 160 mg LY3337641 SD | Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period. |
| FG004 | Placebo MD | Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period. |
| FG005 | 30 mg LY3337641 MD | Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SD | Participants received single oral dose of placebo tablet with a two week follow-up period. |
| BG001 | 5 mg LY3337641 SD | Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period. |
| 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 | Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of LY3337641 or placebo, and have at least one post-dose safety assessment. | Posted | Count of Participants | Participants | No | Up To 31 Days |
|
Up To 31 Days
All enrolled participants.
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 SD | Participants received single oral dose of placebo tablet with a two week follow-up period. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2017 | Feb 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2017 | Feb 6, 2019 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Administered orally. |
|
| PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641 |
AUC from zero to 24-hour of LY3337641 was evaluated. |
| MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose |
| PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation. | MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose |
| BG002 | 80 mg LY3337641 SD | Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period. |
| BG003 | 160 mg LY3337641 SD | Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period. |
| BG004 | Placebo MD | Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period. |
| BG005 | 30 mg LY3337641 MD | Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period. |
| BG006 | Total | Total of all reporting groups |
| 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 |
|
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
| OG002 | 80 mg LY3337641 SD | Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period. |
| OG003 | 160 mg LY3337641 SD | Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period. |
| OG004 | Placebo MD | Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period. |
| OG005 | 30 mg LY3337641 MD | Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641 | Cmax of LY3337641 was evaluated. | All participants who received at least 1 dose of LY3337641 and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose |
|
|
|
| Secondary | PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641 | AUC from zero to 24-hour of LY3337641 was evaluated. | All participants who received at least one dose of LY3337641 and have evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose |
|
|
|
| Secondary | PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation. | All participants who received at least one dose of LY3337641 and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 5 mg LY3337641 SD | Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 80 mg LY3337641 SD | Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 160 mg LY3337641 SD | Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Placebo MD | Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | 30 mg LY3337641 MD | Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period. | 0 | 9 | 0 | 9 | 6 | 9 |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided