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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002506-51 | EudraCT Number |
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The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of caffeine, warfarin, omeprazole and midazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail/ Cocktail + BI 730357 | Experimental | Cocktail treatment will be followed by the Test treatment (Cocktail + BI 730357) in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 20 days between the two cocktail administrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percoffedrinol® | Drug | Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Caffeine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Caffeine) | Area under the concentration-time curve of caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, caffeine) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods. |
| Maximum Measured Concentration of the Caffeine in Plasma (Cmax, Caffeine) | Maximum measured concentration of the caffeine in plasma (Cmax, caffeine) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods. |
| Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, S-warfarin) | Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Area under the concentration-time curve of S-warfarin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity,S-warfain) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods. |
| Maximum Measured Concentration of the S-warfarin in Plasma (Cmax, S-warfarin) | Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Maximum measured concentration of the S-warfarin in plasma (Cmax) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods. |
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Inclusion Criteria:
Healthy subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Either male subject, or female subject who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a phase 1, non-randomised, open-label, 2-treatment, 2-period fixed sequence design trial in healthy people to test whether BI 730357 influences the amount of caffeine, warfarin, omeprazole, and midazolam in the blood.
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Cocktail Alone (R) Then Drug Cocktail + BI 730357 (T) | In period 1: Participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2). In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) was administered orally once. The BI 730357+ cocktail was the test treatment (T). The two cocktail administrations were separated by a wash-out period of at least 20 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2020 | Aug 11, 2022 |
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Two Periods (Period 1 and Period 2) for each participant.
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| Coumadin® | Drug | Tablet |
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| Antra MUPS® | Drug | Gastro-resistant tablet |
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| Midazolam-ratiopharm® | Drug | Oral solution |
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| BI 730357 | Drug | Film-coated tablet |
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| Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Omeprazole) |
Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, omeprazole) is reported. |
| Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods. |
| Maximum Measured Concentration of Omeprazole in Plasma (Cmax, Omeprazole) | Maximum measured concentration of omeprazole in plasma (Cmax, omeprazole) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods. |
| Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Midazolam) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, midazolam) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods. |
| Maximum Measured Concentration of Midazolam in Plasma (Cmax, Midazolam) | Maximum measured concentration of midazolam in plasma (Cmax, midazolam) is reported. | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug Cocktail Alone (R) Then Drug Cocktail + BI 730357 (T) | In period 1: Participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2). In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) was administered orally once. The BI 730357+ cocktail was the test treatment (T). The two cocktail administrations were separated by a wash-out period of at least 20 days. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Area Under the Concentration-time Curve of Caffeine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Caffeine) | Area under the concentration-time curve of caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, caffeine) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hours *nanomole/Liter (h*nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods. |
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| Primary | Maximum Measured Concentration of the Caffeine in Plasma (Cmax, Caffeine) | Maximum measured concentration of the caffeine in plasma (Cmax, caffeine) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter (nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods. |
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| Primary | Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, S-warfarin) | Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Area under the concentration-time curve of S-warfarin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity,S-warfain) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours * nanomole/Liter (h*nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods. |
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| Primary | Maximum Measured Concentration of the S-warfarin in Plasma (Cmax, S-warfarin) | Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Maximum measured concentration of the S-warfarin in plasma (Cmax) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter (nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods. |
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| Primary | Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Omeprazole) | Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, omeprazole) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis. | Posted | Geometric Least Squares Mean | Standard Error | hours * nanomole/Liter (h*nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods. |
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| Primary | Maximum Measured Concentration of Omeprazole in Plasma (Cmax, Omeprazole) | Maximum measured concentration of omeprazole in plasma (Cmax, omeprazole) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter (nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods. |
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| Primary | Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Midazolam) | Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, midazolam) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours * nanomole/Liter (h*nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods. |
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| Primary | Maximum Measured Concentration of Midazolam in Plasma (Cmax, Midazolam) | Maximum measured concentration of midazolam in plasma (Cmax, midazolam) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter (nmol/L) | Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods. |
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Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial 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 | Cocktail (Period 1) | In period 1 participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2). | 0 | 16 | 0 | 16 | 3 | 16 |
| EG001 | BI 730357 (Period 2) | In period 2 (Visit 3) participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 until Day 1 of Visit 3, before the first dose of combination of BI and cocktail medications, (up to 14 days). | 0 | 16 | 0 | 16 | 2 | 16 |
| EG002 | BI 730357 + Cocktail (Period 2) | In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day 1 to Day 6 of Visit 3. On Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the drug cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) was administered orally once. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | BI 730357 Total | In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total). The total number of adverse events due to BI 730357 in the second period is reported. | 0 | 16 | 0 | 16 | 2 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharospasm | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2021 | Aug 11, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002110 | Caffeine |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other |
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