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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002889-40 | EudraCT Number |
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The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7017773 | Experimental | Single dose of RO7017773 |
|
| RO7017773 and Itraconazole | Experimental | Single dose of RO7017773 and multiple doses of itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7017773 | Drug | Single doses of RO7017773 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of RO7017773 in Plasma | Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 12 weeks | |
| Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOTRIAL | Rennes | 35042 | France |
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Healthy male and female participants between 18 and 55 years old. Female participants were women of non-childbearing potential (WONCBP).
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| ID | Title | Description |
|---|---|---|
| FG000 | RO7017773 Alone, Then RO7017773 + Itraconazole | In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RO7017773 Alone, Then RO7017773 + Itraconazole | In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state. |
| 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 | Maximum Concentration (Cmax) of RO7017773 in Plasma | The pharmacokinetic set (PKS) included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. This outcome measure is specific to the reported arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole) |
|
12 weeks
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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 | RO7017773 Alone | In Period 1, participants received a single dose of RO7017773 alone in a fed state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 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 | Yes | No | No | Study Protocol | Nov 14, 2018 | Mar 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2019 | Mar 10, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Multiple doses of Itraconazole |
|
|
| From screening visit through Period 2 Day 11 |
| Cmax of Itraconazole in Plasma | Period 2 |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
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| Secondary | Percentage of Participants With Adverse Events (AEs) | The safety set (SS) included all participants who received at least one dose of study treatment and included any participant(s) that were withdrawn from the study. | Posted | Number | Percentage of Participants | 12 weeks |
|
|
|
| Secondary | Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. | The included set (IS) contained all study participants. | Posted | Mean | Standard Deviation | Units on a scale | From screening visit through Period 2 Day 11 |
|
|
|
| Secondary | Cmax of Itraconazole in Plasma | The pharmacokinetic set (PKS) included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. This outcome measure is specific to the reported arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | Itraconazole Alone | In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG002 | RO7017773 + Itraconazole | In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state. | 0 | 13 | 0 | 13 | 7 | 13 |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | 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.
| D010879 |
| Piperazines |