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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA047720 | U.S. NIH Grant/Contract | View source | |
| 406190 | Other Identifier | NIH ERA Human Subjects Study Number |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| New York State Psychiatric Institute | OTHER |
| Columbia University | OTHER |
| Clinilabs, Inc. |
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This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).
This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivitrol (naltrexone) | Experimental | Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone 380 MG | Drug | Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Cmax of Naltrexone (After 1st Dose) | Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Tmax of Naltrexone (After 1st Dose) | Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median AUC0-inf of Naltrexone (After 1st Dose) | Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Ctrough of Naltrexone (After 1st Dose) | Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Cmax of 6β-naltrexol (After First Dose) | Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Tmax of 6β-naltrexol (After 1st Dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Proportion of participants reporting AEs | Up to Day 196 |
| Naltrexone Accumulation Ratio (AR) for Cmax | The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bisaga, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivitrol (Naltrexone) | Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivitrol (Naltrexone) | Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Median Cmax of Naltrexone (After 1st Dose) | Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
196 days
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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 | Vivitrol (Naltrexone) | Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart. Naltrexone 380 MG: Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Operations | Go Medical Industries, Pty Ltd | 61(8) 9388 1700 | ctc@gomedical.com.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2021 | Apr 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2021 | Apr 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| OTHER |
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Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0
| 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median AUC0-inf of 6β-naltrexol (After 1st Dose) | Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Ctrough of 6β-naltrexol (After 1st Dose) | Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
| Median Cmax of Naltrexone (After 6th Dose) | PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median Tmax of Naltrexone (After 6th Dose) | PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median AUC0-inf of Naltrexone (After 6th Dose) | PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median Ctrough of Naltrexone (After 6th Dose) | PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median Cmax of 6β-naltrexol (After 6th Dose) | PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median Tmax of 6β-naltrexol (After th Dose) | PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median AUC0-inf of 6β-naltrexol (After 6th Dose) | PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| Median Ctrough of 6β-naltrexol (After 6th Dose) | PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
| 196 days after the 6th dose |
| Naltrexone Accumulation Ratio (AR) for Ctrough | The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | 196 days after the 6th dose |
| Naltrexone Accumulation Ratio (AR) for AUC0-inf | The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | 196 days after the 6th dose |
| 6β-naltrexol Accumulation Ratio (AR) for Cmax | The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | 196 days after the 6th dose |
| 6β-naltrexol Accumulation Ratio (AR) for Ctrough | The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | 196 days after the 6th dose |
| 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf | The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | 196 days after the 6th dose |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m^2) | Median | Inter-Quartile Range | kg/m^2 |
|
|
|
| Primary | Median Tmax of Naltrexone (After 1st Dose) | Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | day | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median AUC0-inf of Naltrexone (After 1st Dose) | Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | day*ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median Ctrough of Naltrexone (After 1st Dose) | Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median Cmax of 6β-naltrexol (After First Dose) | Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median Tmax of 6β-naltrexol (After 1st Dose) | Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | day | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median AUC0-inf of 6β-naltrexol (After 1st Dose) | Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | day*ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median Ctrough of 6β-naltrexol (After 1st Dose) | Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0 | Posted | Median | Inter-Quartile Range | ng/mL | 1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28. |
|
|
|
| Primary | Median Cmax of Naltrexone (After 6th Dose) | PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140 | Posted | Median | Inter-Quartile Range | ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median Tmax of Naltrexone (After 6th Dose) | PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | day | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median AUC0-inf of Naltrexone (After 6th Dose) | PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | day*ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median Ctrough of Naltrexone (After 6th Dose) | PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median Cmax of 6β-naltrexol (After 6th Dose) | PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median Tmax of 6β-naltrexol (After th Dose) | PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | day | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median AUC0-inf of 6β-naltrexol (After 6th Dose) | PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | day*ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
|
|
| Primary | Median Ctrough of 6β-naltrexol (After 6th Dose) | PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140 | Posted | Median | Inter-Quartile Range | ng/mL | 6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196 |
|
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|
| Secondary | Adverse Events (AEs) | Proportion of participants reporting AEs | Posted | Count of Participants | Participants | Up to Day 196 |
|
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|
| Secondary | Naltrexone Accumulation Ratio (AR) for Cmax | The naltrexone AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| Secondary | Naltrexone Accumulation Ratio (AR) for Ctrough | The naltrexone AR was determined for Crough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| Secondary | Naltrexone Accumulation Ratio (AR) for AUC0-inf | The naltrexone AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| Secondary | 6β-naltrexol Accumulation Ratio (AR) for Cmax | The 6β-naltrexol AR was determined for Cmax by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| Secondary | 6β-naltrexol Accumulation Ratio (AR) for Ctrough | The 6β-naltrexol AR was determined for Ctrough by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| Secondary | 6β-naltrexol Accumulation Ratio (AR) for AUC0-inf | The 6β-naltrexol AR was determined for AUC0-inf by dividing the PK parameter for Dose 6 by the PK parameter for Dose 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 196 days after the 6th dose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Aborted pregnancy | Social circumstances | MedDRA 21.0 | Systematic Assessment |
|
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |