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The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts:
Part A
Part B
Part A is an open-label, randomized, single dose, 3-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered either with or without cobicistat, under fasting conditions or following a standardized high-fat/high-calorie meal. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. Participants will be confined for total of 19 days.
Part B is an open-label, randomized, single dose, 4-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered without cobicistat, under fasting conditions, following a standardized high-fat/high-calorie meal without cobicistat, or following a low-fat meal with or without cobicistat. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. participants will be confined for total of 19 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state). |
|
| Treatment 2 | Experimental | Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state). |
|
| Treatment 3 | Experimental | Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state). |
|
| Treatment A | Experimental | Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state). |
|
| Treatment B | Experimental | Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plixorafenib | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs). | Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs). | First dose of Plixorafenib to day 19 (Treatment Period 3). |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t). | Area under the concentration versus time curve from time 0 to the last quantifiable concentration within the dosing interval. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| AUC From Time 0 Extrapolated to Infinity (AUC0-inf). | Area under the concentration versus time curve from time 0 extrapolated to infinity calculated as AUC0-t + Clast/λz, where Clast is the last quantifiable concentration and lambda z is the terminal rate constant. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Maximum Observed Plasma Concentration (Cmax). | Maximum observed concentration, obtained by inspection. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Time to Maximum Observed Plasma Concentration (Tmax). | Time at which the maximum concentration was observed, obtained by inspection. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Terminal Elimination Rate Constant (λz). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Amount of Plixorafenib Excreted in Urine(Ae) | The cumulative amount of plixorafenib in urine from 0 to 48 hours, Ae,48, was calculated for the Part A participants only as the sum between 0 and 48 hours of the product of the urine concentration and the urine volume for each collection interval by participant for each treatment. | Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period. |
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Inclusion Criteria:
The participant is able to provide written informed consent.
Healthy male or non-pregnant, non-lactating female participants aged 18 to 55 years, inclusive, with a BMI of 18 kg/m2 or greater, but less than 30 kg/m2. The participant is considered by the investigator to be in good general health status as determined by physical examination, vital signs, temperature, medical history, no clinically significant abnormalities at investigator's discretion in laboratory and urine analyses, and with normal organ function as defined below:
Healthy female participants must be:
Documented to be surgically sterile (surgical methods inclusive of hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or postmenopausal (amenorrhea for ≥24 months without an alternative medical cause and FSH ≥30 mIU/mL).
OR
Using contraception, including 1 highly effective nonhormonal methods (eg, intrauterine device) in combination with a barrier contraception (eg, male or female condoms, diaphragm, spermicide, etc.) from start of plixorafenib administration until 30 days after the last plixorafenib administration, and having a negative serum or urine β-hCG pregnancy test (with a sensitivity of at least 25 mIU/mL) at screening and check in.
Male participants with female partners of childbearing potential must be sterile (confirmed by documented azoospermia 90 days after the procedure) or agree to use (from check-in until 90 days after discharge) one of the following approved methods of contraception: male condom with spermicide; sterile sexual partner (males must still agree to use condom with their surgically sterile female partner if unable to provide documentation of partner's sterility); or practice abstinence (abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant, periodic abstinence won't be allowed); or use of an intrauterine device with spermicide by female sexual partner; a female condom with spermicide; a contraceptive sponge with spermicide; an intravaginal system; a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives.
Male participants must refrain from sperm donation and female participants must refrain from egg donation from check-in until 90 days after discharge from the study.
The participant agrees to comply with all protocol requirements for the duration of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie P Shepherd, MD, PhD | Fore Biotherapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD - Austin Research Unit | Austin | Texas | 78744 | United States |
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1 Clinical site located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Sequence 1 | Participants that completed the following treatment periods in sequence:
|
| FG001 | Part A: Sequence 2 | Participants that completed the following treatment periods in sequence:
|
| FG002 | Part A: Sequence 3 | Participants that completed the following treatment periods in sequence:
|
| FG003 | Part A: Sequence 4 | Participants that completed the following treatment periods in sequence:
|
| FG004 | Part A: Sequence 5 | Participants that completed the following treatment periods in sequence:
|
| FG005 | Part A: Sequence 6 | Participants that completed the following treatment periods in sequence:
|
| FG006 | Part B: Sequence 1 | Participants that completed the following treatment periods in sequence:
|
| FG007 | Part B: Sequence 2 | Participants that completed the following treatment periods in sequence:
|
| FG008 | Part B: Sequence 3 | Participants that completed the following treatment periods in sequence:
|
| FG009 | Part B: Sequence 4 | Participants that completed the following treatment periods in sequence:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Sequence 1 | Participants that completed the following treatment periods in sequence:
|
| BG001 |
| 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 Treatment Emergent Adverse Events (TEAEs). | Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs). | Posted | Count of Participants | Participants | First dose of Plixorafenib to day 19 (Treatment Period 3). |
|
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
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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 | Treatment 1 | Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state). Plixorafenib: Oral Tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stacie Shepherd | FORE Biotherapeutics | 267-641-7575 | stacie.shepherd@fore.bio |
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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 | Oct 3, 2024 | Dec 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2024 | Dec 22, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2024 | Dec 22, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Treatment C |
| Experimental |
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal). |
|
| Treatment D | Experimental | Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal). |
|
|
| Cobicistat | Drug | Oral Tablet |
|
|
Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.
| Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Terminal Phase Half-life (t1/2). | Terminal half-life, calculated as ln (2)/λz. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Apparent Oral Clearance (CL/F). | Oral clearance, calculated as Dose/AUC0 inf. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Apparent Volume of Distribution (Vz/F). | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection. | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
| Percent of Dose Excreted in Urine in 48 Hours. | The percent of the dose excreted in urine in 48 hours (fe,48%) was calculated as Ae,48*100/Dose. | Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period. |
| Part A: Sequence 2 |
Participants that completed the following treatment periods in sequence:
|
| BG002 | Part A: Sequence 3 | Participants that completed the following treatment periods in sequence:
|
| BG003 | Part A: Sequence 4 | Participants that completed the following treatment periods in sequence:
|
| BG004 | Part A: Sequence 5 | Participants that completed the following treatment periods in sequence:
|
| BG005 | Part A: Sequence 6 | Participants that completed the following treatment periods in sequence:
|
| BG006 | Part B: Sequence 1 | Participants that completed the following treatment periods in sequence:
|
| BG007 | Part B: Sequence 2 | Participants that completed the following treatment periods in sequence:
|
| BG008 | Part B: Sequence 3 | Participants that completed the following treatment periods in sequence:
|
| BG009 | Part B: Sequence 4 | Participants that completed the following treatment periods in sequence:
|
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| OG002 | Treatment 3 | Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state). Plixorafenib: Oral Tablet Cobicistat: Oral Tablet |
| OG003 | Treatment A | Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state). Plixorafenib: Oral Tablet |
| OG004 | Treatment B | Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal). Plixorafenib: Oral Tablet |
| OG005 | Treatment C | Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal). Plixorafenib: Oral Tablet |
| OG006 | Treatment D | Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal). Plixorafenib: Oral Tablet Cobicistat: Oral Tablet |
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t). | Area under the concentration versus time curve from time 0 to the last quantifiable concentration within the dosing interval. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | h*µg/mL | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | AUC From Time 0 Extrapolated to Infinity (AUC0-inf). | Area under the concentration versus time curve from time 0 extrapolated to infinity calculated as AUC0-t + Clast/λz, where Clast is the last quantifiable concentration and lambda z is the terminal rate constant. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) < 0.75 and the value was excluded from summary statistics. | Posted | Mean | Standard Deviation | h*µg/mL | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax). | Maximum observed concentration, obtained by inspection. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | µg/mL | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Time to Maximum Observed Plasma Concentration (Tmax). | Time at which the maximum concentration was observed, obtained by inspection. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | h | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Terminal Elimination Rate Constant (λz). | Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) < 0.75 and the value was excluded from summary statistics. | Posted | Mean | Standard Deviation | 1/h | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Terminal Phase Half-life (t1/2). | Terminal half-life, calculated as ln (2)/λz. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) < 0.75 and the value was excluded from summary statistics. | Posted | Mean | Standard Deviation | h | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Apparent Oral Clearance (CL/F). | Oral clearance, calculated as Dose/AUC0 inf. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) < 0.75 and the value was excluded from summary statistics. | Posted | Mean | Standard Deviation | L/h | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F). | All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) < 0.75 and the value was excluded from summary statistics. | Posted | Mean | Standard Deviation | L | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Primary | Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection. | All participants enrolled into Part A and Part B who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | h | Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period. |
|
|
|
| Secondary | Cumulative Amount of Plixorafenib Excreted in Urine(Ae) | The cumulative amount of plixorafenib in urine from 0 to 48 hours, Ae,48, was calculated for the Part A participants only as the sum between 0 and 48 hours of the product of the urine concentration and the urine volume for each collection interval by participant for each treatment. | All participants enrolled into Part A only who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | mg | Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period. |
|
|
|
| Secondary | Percent of Dose Excreted in Urine in 48 Hours. | The percent of the dose excreted in urine in 48 hours (fe,48%) was calculated as Ae,48*100/Dose. | All participants enrolled into Part A only who received 900mg plixorafenib. | Posted | Mean | Standard Deviation | percent | Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Treatment 2 | Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state). Plixorafenib: Oral Tablet Cobicistat: Oral Tablet | 0 | 12 | 0 | 12 | 1 | 12 |
| EG002 | Treatment 3 | Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state). Plixorafenib: Oral Tablet Cobicistat: Oral Tablet | 0 | 12 | 0 | 12 | 1 | 12 |
| EG003 | Treatment A | Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state). Plixorafenib: Oral Tablet | 0 | 12 | 0 | 12 | 2 | 12 |
| EG004 | Treatment B | Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal). Plixorafenib: Oral Tablet | 0 | 12 | 0 | 12 | 3 | 12 |
| EG005 | Treatment C | Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal). Plixorafenib: Oral Tablet | 0 | 12 | 0 | 12 | 4 | 12 |
| EG006 | Treatment D | Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal). Plixorafenib: Oral Tablet Cobicistat: Oral Tablet | 0 | 12 | 0 | 12 | 1 | 12 |
| Dysgeusia | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Medical device site dermatitis | General disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 27.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 27.0 | Systematic Assessment |
|
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| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |