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| ID | Type | Description | Link |
|---|---|---|---|
| I4J-MC-HHBG | Other Identifier | Eli Lilly and Company |
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This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the safety and side effects of LY2940680 in healthy participants. Part A will involve two groups of participants, each taking up to two single doses of LY2940680 at different dose levels. There is a minimum 14 day washout period between each of the participant's doses. The purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets into the bloodstream and how long the body takes to get rid of it. In addition, the effect of food and a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a minimum 7 day washout period between doses. Participants may only enroll in one part. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2940680 (Part A) | Experimental | Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods |
|
| Placebo (Part A) | Placebo Comparator | Placebo given once orally in up to 1 of 2 study periods |
|
| LY2940680 Capsule Fasted (Part B) | Experimental | 100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods |
|
| LY2940680 Tablet Fasted (Part B) | Experimental | 100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods |
|
| LY2940680 Tablet Fed (Part B) | Experimental | 100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2940680 Capsule(s) (Reference) | Drug | Administered orally as a capsule(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section. | Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B) |
| Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | The Cmax of LY2940680 during Part A of the study was reported. | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
| Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) |
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Inclusion Criteria:
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. | Dallas | Texas |
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This randomized single-dose study consisted of 2 parts. Part A had Cohorts 1 and 2 receive ascending doses of LY2940680 and placebo over 2 periods. Part B had Cohort 3 receive 1 of 2 treatment sequences over 4 separate periods to evaluate tablet versus capsule (reference) formulation, and the effects of food and proton pump inhibitor (PPI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Cohort 1, Sequence 1 | 50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG001 | Part A, Cohort 1, Sequence 2 | 50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG002 | Part A, Cohort 1, Sequence 3 | Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG003 | Part A, Cohort 2, Sequence 4 | 100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG004 | Part A, Cohort 2, Sequence 5 | 100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG005 | Part A, Cohort 2, Sequence 6 | Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| FG006 | Part B, Cohort 3, Sequence 1 | 100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. |
| FG007 | Part B, Cohort 3, Sequence 2 | 100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period From First Intervention |
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| Second Intervention |
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| Washout Period From Second Intervention |
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| Third Intervention |
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| Washout Period From Third Intervention |
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| Fourth Intervention |
|
All randomized participants in Part A and B of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Cohort 1, Sequence 1 | 50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study |
| BG001 | Part A, 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 1 or More Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section. | All randomized participants. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B) |
|
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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 Capsule (Fasted) | Placebo capsule given once orally in fasted state during Part A of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| C581399 | LY2940680 |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| LY2940680 Tablet Fasted + PPI (Part B) |
| Experimental |
30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods |
|
| LY2940680 Tablet (Test) | Drug | Administered orally as a tablet |
|
| Lansoprazole | Drug | Administered orally as a capsule |
|
| Placebo Capsule(s) | Drug | Administered orally as a capsule(s) |
|
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) |
| Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
| Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
| Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
| Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
| Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
| Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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|
50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| BG002 | Part A, Cohort 1, Sequence 3 | Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| BG003 | Part A, Cohort 2, Sequence 4 | 100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| BG004 | Part A, Cohort 2, Sequence 5 | 100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| BG005 | Part A, Cohort 2, Sequence 6 | Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. |
| BG006 | Part B, Cohort 3, Sequence 1 | 100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. |
| BG007 | Part B, Cohort 3, Sequence 2 | 100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. |
| BG008 | 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 |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | 100-mg LY2940680 Capsule (Fasted) Part A | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| OG003 | 100-mg LY2940680 Capsule (Fasted) Part B | 100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study. |
| OG004 | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. |
| OG005 | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor(PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study. |
| OG006 | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study. |
| OG007 | 200-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| OG008 | 400-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
|
|
| Primary | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study. | Analysis was based on the number of randomized participants in Part B of the study with evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug |
|
|
|
| Secondary | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | The Cmax of LY2940680 during Part A of the study was reported. | Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
|
|
|
| Secondary | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) | Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. | Posted | Median | Full Range | hours (h) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
|
|
|
| Secondary | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) | Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study. | Posted | Median | Full Range | hours (h) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
|
|
|
| Secondary | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] | Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
|
|
|
| Secondary | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] | Analysis was based on the number of randomized participants who received LY2940680 who had evaluable PK data during Part B of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
|
|
|
| Secondary | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug |
|
|
|
| Secondary | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug |
|
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | 50-mg LY2940680 Capsule (Fasted) | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 0 | 6 | 3 | 6 |
| EG002 | 100-mg LY2940680 Capsule (Fasted) Part A or Part B | 100-mg LY2940680 capsule administered once orally in fasted state during Part A or Part B of the study. | 0 | 20 | 10 | 20 |
| EG003 | 100 mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 0 | 14 | 5 | 14 |
| EG004 | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor (PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study. | 0 | 11 | 3 | 11 |
| EG005 | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study. | 0 | 12 | 5 | 12 |
| EG006 | 200-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 0 | 6 | 3 | 6 |
| EG007 | 400-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 0 | 5 | 3 | 5 |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |