Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503449-79-00 | EU Trial (CTIS) Number | EU CTIS |
Not provided
Not provided
Not provided
Business reasons
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.
The study consists of two parts. In Part A, participants will receive a single infusion of C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for up to 1 year.
The drug being tested in this study is called [14C]subasumstat. [14C]Subasumstat is being tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of people who have advanced or metastatic solid tumors.
The study will enroll approximately 10 patients. Participants will be enrolled to receive a single dose of [14C]subasumstat:
- [14C]Subasumstat 90 mg
Participants will be administered with a single dose of [14C]subasumstat 90 mg as a 1-hour intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14 days postdose. Participants will then have an option to enter Part B of the study to receive non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle for 3 cycles up to maximum treatment duration of 1 year.
This multi-center trial will be conducted in Hungary. The overall study duration is 12 months for Part A and 24 months for Part B.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: [14C] Subasumstat | Experimental | Participants received a single dose of [14C] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study. |
|
| Part B: Subasumstat | Experimental | Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] Subasumstat | Drug | [14C] Subasumstat IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Urinary Recovery | Cumulative percentage of [14C]-radioactivity excreted in urine up to the last sampling interval. | Up to 14 days post-dose |
| Cumulative Percentage of Fecal Recovery | Cumulative percentage of [14C]-radioactivity excreted in feces up to the last sampling interval. | Up to 14 days post-dose |
| Cumulative Percentage of Combined Recovery | Cumulative percentage of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval. | Up to 14 days post-dose |
| Percentage Of Recovered Total Radioactivity (TRA) In Urine | Percentage of recovered TRA in urine for each interval over the entire period of collection were reported. | Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr |
| Percentage Of Recovered Total Radioactivity (TRA) In Feces | Percentage of recovered TRA in feces for each interval over the entire period of collection were reported. | Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr | |
| Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital of Northern Pest - Military Hospital | Budapest | 1062 | Hungary | |||
| Pharmaceutical Research Associates Magyarorszag |
Not provided
| Label | URL |
|---|---|
| To obtain more information on the study, click this link. | View source |
Not provided
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
Not provided
Not provided
Not provided
Not provided
Participants with advanced or metastatic solid tumors were enrolled in this study to receive [14C] subasumstat in Part A and subasumstat in Part B of this study.
3 participants took part in the study at 1 investigative site in Hungary from 14 November 2023 to 16 July 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: [14C] Subasumstat | Participants received a single dose of [14C] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study. |
| FG001 | Part B: Subasumstat | Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| |||||||||||||
| Part B |
|
Safety Analysis Set (SAS) comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: [14C] Subasumstat | Participants received a single dose of [14C] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Percentage of Urinary Recovery | Cumulative percentage of [14C]-radioactivity excreted in urine up to the last sampling interval. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | Up to 14 days post-dose |
|
|
Up to approximately 8 months
SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [14C] Subasumstat | Participants received a single dose of [14C] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
The enrollment for the study was halted by the sponsor for business reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2023 | Jun 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2023 | Jun 20, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000730454 | TAK-981 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Subasumstat | Drug | Subasumstat IV infusion. |
|
|
| Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr 4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
| Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine) | Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat. | Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14 |
| Renal Clearance (CLR) for Subasumstat in Urine | Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14 |
| Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. | Up to approximately 8 months |
| Number of Participants With One or More Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. | Up to approximately 8 months |
| Number of Participants With Abnormal Electrocardiogram Findings | Abnormal laboratory values are those outside of normal range as assessed by the investigator. | Up to approximately 8 months |
| Number of Participants With Abnormal Laboratory Values | Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator. | Up to approximately 8 months |
| Relative Percentage of Circulatory Metabolites in Plasma | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
| Relative Percentage Excretory Metabolites in Urine | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
| Relative Percentage of Excretory Metabolites in Feces | M1, M9 and M10 reported as categories were the names for the metabolites. | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
| Budapest |
| 1077 |
| Hungary |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Cumulative Percentage of Fecal Recovery | Cumulative percentage of [14C]-radioactivity excreted in feces up to the last sampling interval. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | Up to 14 days post-dose |
|
|
|
| Primary | Cumulative Percentage of Combined Recovery | Cumulative percentage of [14C]-radioactivity excreted in urine, and feces up to the last sampling interval. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage | Up to 14 days post-dose |
|
|
|
| Primary | Percentage Of Recovered Total Radioactivity (TRA) In Urine | Percentage of recovered TRA in urine for each interval over the entire period of collection were reported. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr |
|
|
|
| Primary | Percentage Of Recovered Total Radioactivity (TRA) In Feces | Percentage of recovered TRA in feces for each interval over the entire period of collection were reported. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr 4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr |
|
|
| Secondary | Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine) | Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Mean | Standard Deviation | % of dose | Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14 |
|
|
|
| Secondary | Renal Clearance (CLR) for Subasumstat in Urine | Based on Primary Analysis results, lack of generalizability and accuracy of the urine analysis and missing data for relevant PK parameters, it would not have been possible to report the accurate data without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14 |
|
|
| Secondary | Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Number | participants | Up to approximately 8 months |
|
|
|
| Secondary | Number of Participants With One or More Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Number | participants | Up to approximately 8 months |
|
|
|
| Secondary | Number of Participants With Abnormal Electrocardiogram Findings | Abnormal laboratory values are those outside of normal range as assessed by the investigator. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Number | participants | Up to approximately 8 months |
|
|
|
| Secondary | Number of Participants With Abnormal Laboratory Values | Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Number | participants | Up to approximately 8 months |
|
|
|
| Secondary | Relative Percentage of Circulatory Metabolites in Plasma | The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of. | Posted | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
|
|
| Secondary | Relative Percentage Excretory Metabolites in Urine | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Mean | Standard Deviation | % of dose | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
|
|
|
| Secondary | Relative Percentage of Excretory Metabolites in Feces | M1, M9 and M10 reported as categories were the names for the metabolites. | SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. | Posted | Mean | Standard Deviation | % of dose | Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr |
|
|
|
| 1 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Subasumstat | Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year. | 1 | 2 | 1 | 2 | 2 | 2 |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
|
| Day 2- 12-24 hr |
|
|
| Day 3- 24-48 hr |
|
|
| Day 4- 48-72 hr |
|
|
| Day 5- 72-96 hr |
|
|
| Day 6- 96-120 hr |
|
|
| Day 7- 120-144 hr |
|
|
| Day 8- 144-168 hr |
|
|
| Day 9- 168-192 hr |
|
|
| Day 10- 192-216 hr |
|
|
| Day 11- 216-240 hr |
|
|
| Day 12- 240-264 hr |
|
|
|
| Day 4- 48-72 hr |
|
|
| Day 5- 72-96 hr |
|
|
| Day 6- 96-120 hr |
|
|
| Day 7- 120-144 hr |
|
|
| Day 8- 144-168 hr |
|
|
| Day 9- 168-192 hr |
|
|
| Day 10- 192-216 hr |
|
|
| Day 11- 216-240 hr |
|
|
| Urinalysis |
|
| Title | Measurements |
|---|---|
|