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The main purpose of the study is to characterize the interaction between RO7049389 and the cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical benefit to this study. The total duration of the study for each participant is approximately 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental | Period 1: Participants will receive a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 and up to 21 days. Period 2: Participants will receive RO7049389 on Days 1-6. Participants will also receive a single dose of pitavastatin on Day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7049389 | Drug | RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin | Period 1 Day 1 | |
| Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | Period 1 Day 1 | |
| Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin | Period 1 Day 1 | |
| Period 1: Apparent Total Clearance (CL/F) of Pitavastatin | Period 1 | |
| Period 1: Volume of Distribution (V/F) of Pitavastatin | Period 1 Day 1 | |
| Period 1: Elimination Half-Life (T1/2) of Pitavastatin | Period 1 Day 1 | |
| Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin | Period 2 Day 4 | |
| Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | Period 2 Day 4 | |
| Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin | Period 2 Day 4 | |
| Period 2: Apparent Total Clearance (CL/F) of Pitavastatin | Period 2 Day 4 | |
| Period 2: Volume of Distribution (V/F) of Pitavastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-LaRoche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Research Unit - Daytona | Daytona Beach | Florida | 32117 | United States |
This study had two periods. Period 1: Participants received a single dose of pitavastatin, followed by a washout period of 7-21 days. Period 2: Participants received a single dose of pitavastatin along with a twice-daily dose of RO7049389.
This study recruited healthy adult participants at one site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin/RO7049389 | Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin/RO7049389 | Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4. |
| 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 | Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1 Day 1 |
|
|
From the start of Period 1 through safety follow-up (Period 2, Day 34)
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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 | Pitavastatin/RO7049389 | Period 1: Participants received a single dose of pitavastatin on Day 1, followed by a wash-out period of at least 7 days and up to 21 days. Period 2: Participants received RO7049389 on Days 1-6. Participants also received a single dose of pitavastatin on Day 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 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 | Aug 27, 2018 | Nov 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| Pitavastatin | Drug | Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2. |
|
| Period 2 Day 4 |
| Period 2: Elimination Half-Life (T1/2) of Pitavastatin | Period 2 Day 4 |
| From the start of Period 1 through safety follow-up (Period 2, Day 34) |
| Period 2: Cmax of RO7049389 | Period 2 Days 3-4 |
| Period 2: AUC-tau of RO7049389 | Period 2 Days 3-4 |
| Period 1: Cmax of Pitavastatin Lactone | Period 1 Day 1 |
| Period 1: AUC0-inf of Pitavastatin Lactone | Period 1 Day 1 |
| Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin | Period 1 Day 1 |
| Period 2: Cmax of Pitavastatin Lactone | Period 2 Day 4 |
| Period 2: AUC0-inf of Pitavastatin Lactone | Period 2 Day 4 |
| Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin | Period 2 Day 4 |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Period 1 Day 1 |
|
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| Primary | Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin | Posted | Median | Full Range | hours (h) | Period 1 Day 1 |
|
|
|
| Primary | Period 1: Apparent Total Clearance (CL/F) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Period 1 |
|
|
|
| Primary | Period 1: Volume of Distribution (V/F) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Period 1 Day 1 |
|
|
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| Primary | Period 1: Elimination Half-Life (T1/2) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Period 1 Day 1 |
|
|
|
| Primary | Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2 Day 4 |
|
|
|
| Primary | Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Period 2 Day 4 |
|
|
|
| Primary | Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin | Posted | Median | Full Range | h | Period 2 Day 4 |
|
|
|
| Primary | Period 2: Apparent Total Clearance (CL/F) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Period 2 Day 4 |
|
|
|
| Primary | Period 2: Volume of Distribution (V/F) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Period 2 Day 4 |
|
|
|
| Primary | Period 2: Elimination Half-Life (T1/2) of Pitavastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Period 2 Day 4 |
|
|
|
| Secondary | Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Posted | Number | Percentage of Participants | From the start of Period 1 through safety follow-up (Period 2, Day 34) |
|
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| Secondary | Period 2: Cmax of RO7049389 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2 Days 3-4 |
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| Secondary | Period 2: AUC-tau of RO7049389 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Period 2 Days 3-4 |
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| Secondary | Period 1: Cmax of Pitavastatin Lactone | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 1 Day 1 |
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| Secondary | Period 1: AUC0-inf of Pitavastatin Lactone | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Period 1 Day 1 |
|
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| Secondary | Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Period 1 Day 1 |
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| Secondary | Period 2: Cmax of Pitavastatin Lactone | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2 Day 4 |
|
|
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| Secondary | Period 2: AUC0-inf of Pitavastatin Lactone | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Period 2 Day 4 |
|
|
|
| Secondary | Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Period 2 Day 4 |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 7 |
| 18 |
| Nausea | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v21.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1 | Non-systematic Assessment |
|
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.