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The objective of this study is to characterize the mass balance, absolute bioavailability, route and rates of elimination of RO7049839.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mass Balance (MB) Cohort | Experimental | Participants will receive oral [14C] RO7049389 under fasted conditions, followed by intravenous IV [13C] after a two-hour period. |
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| Absolute Bioavailability (BA) Cohort | Experimental | In Periods 1 and 2, participants will receive oral [12C] RO7049389 under fasted conditions, followed by IV [13C] RO7049389. There is a minimum 7-day washout between periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [12C] RO7049389 | Drug | Participants will receive oral [12C] RO7049389. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Dose Excreted in Urine - MB Cohort | Up to Day 17 | |
| Percentage of Dose Excreted in Feces - MB Cohort | Up to Day 17 | |
| Percent Total Recovery (Urine + Feces) - MB Cohort | Up to Day 17 | |
| Absolute Oral BA for RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) of RO7049389 - MB Cohort | Up to Day 17 | |
| Clearance (CL) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 | |
| Half-Life (T1/2) of RO7049389 - MB Cohort |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Mass Balance Cohorts
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Absolute Bioavailability (BA) Cohort | Period 1: Participants received 600 mg of oral [12C] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. Period 2: After a 7-day washout period, participants received 1000 mg of oral [12C] RO7049389, followed by 100 ug of IV [13C] RO7049389 after a two-hour delay. |
| FG001 | Mass Balance (MB) Cohort | Participants received 600 mg of [14C] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. (Note: [14C] RO7049389 was a combination of [12C]+[14C]-labeled RO7049389). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Absolute Bioavailability (BA) Cohort | Period 1: Participants received 600 mg of oral [12C] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. Period 2: After a 7-day washout period, participants received 1000 mg of oral [12C] RO7049389, followed by 100 ug of IV [13C] RO7049389 after a two-hour delay. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Dose Excreted in Urine - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Up to Day 17 |
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MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
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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 | Absolute Bioavailability (BA) Cohort | Period 1: Participants received 600 mg of oral [12C] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. Period 2: After a 7-day washout period, participants received 1000 mg of oral [12C] RO7049389, followed by 100 ug of IV [13C] RO7049389 after a two-hour delay. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid rash | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann - LaRoche | 1-800-821-8590 | genentech@druginfo.com |
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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 | Apr 15, 2021 | Jun 6, 2022 | Prot_SAP_000.pdf |
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| [13C] RO7049389 | Drug | Participants will receive IV [13C] RO7049389. |
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| [14C] RO7049389 | Drug | Participants will receive an oral suspension of [14C] RO7049389. |
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| Up to Day 17 |
| Half-Life (T1/2) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort | Up to Day 17 |
| Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort | Up to Day 17 |
| Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort | Up to Day 4 |
| Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - MB Cohort | Up to Day 17 |
| Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Apparent Clearance (CL/F) of RO7049389 - MB Cohort | Up to Day 4 |
| Apparent Clearance (CL/F) of RO7049389 - BA Cohort | Up to Day 4 |
| Renal Clearance (CLr) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort | Up to Day 4 of Periods 1 and 2 |
| Percentage of Participants With Adverse Events (AEs) | Up to Day 29 (MB Cohort) or up to Day 29 of Period 2 (AB Cohort) |
| NOT COMPLETED |
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| BG001 | Mass Balance (MB) Cohort | Participants received 600 mg of [14C] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. (Note: [14C] RO7049389 was a combination of [12C]+[14C]-labeled RO7049389). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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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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| Primary | Percentage of Dose Excreted in Feces - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Up to Day 17 |
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| Primary | Percent Total Recovery (Urine + Feces) - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Up to Day 17 |
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| Primary | Absolute Oral BA for RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Clearance (CL) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Up to Day 17 |
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| Secondary | Clearance (CL) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Half-Life (T1/2) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Up to Day 17 |
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| Secondary | Half-Life (T1/2) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to Day 17 |
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| Secondary | Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort | Posted | Median | Full Range | Hours | Up to Day 17 |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Median | Full Range | Hours | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Up to Day 4 |
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| Secondary | Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Up to Day 17 |
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| Secondary | Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Apparent Clearance (CL/F) of RO7049389 - MB Cohort | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Up to Day 4 |
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| Secondary | Apparent Clearance (CL/F) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Up to Day 4 |
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| Secondary | Renal Clearance (CLr) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort | All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis. | Posted | Mean | Standard Deviation | mg | Up to Day 4 of Periods 1 and 2 |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | Posted | Number | Percentage of participants | Up to Day 29 (MB Cohort) or up to Day 29 of Period 2 (AB Cohort) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 13 |
| 16 |
| EG001 | Mass Balance (MB) Cohort | Participants received 600 mg of [14C] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) [13C] RO7049389 after a two-hour delay. (Note: [14C] RO7049389 was a combination of [12C]+[14C]-labeled RO7049389). | 0 | 6 | 0 | 6 | 2 | 6 |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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