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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519277-18-00 | EU Trial (CTIS) Number |
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This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ROS Alone, Then PIT Alone, Then RO7795081 Alone, Then RO7795081 + ROS, Then RO7795081 + PIT | Experimental | Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: RO7795081 alone; Period 4: RO7795081 in combination with ROS; Period 5: RO7795081 in combination with PIT |
|
| Arm 2: ROS Alone, Then PIT Alone, Then Placebo Alone, Then Placebo + ROS, Then Placebo + PIT | Placebo Comparator | Period 1: Rosuvastatin (ROS) alone; Period 2: Pitavastatin (PIT) alone; Period 3: Placebo alone; Period 4: Placebo in combination with ROS; Period 5: Placebo in combination with PIT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7795081 | Drug | RO7795081 will be administered orally during Periods 3, 4, and 5, according to the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events | From the first dose of study treatment until the final visit (up to 111 days) | |
| Incidence of Abnormal Clinical Laboratory Test Results | From the first dose of study treatment until the final visit (up to 111 days) | |
| Incidence of Abnormal Vital Sign Assessments | From the first dose of study treatment until the final visit (up to 111 days) | |
| Incidence of Abnormal Electrocardiogram Parameters | From the first dose of study treatment until the final visit (up to 111 days) | |
| Maximum Plasma Concentration Observed (Cmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 | |
| Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 | |
| Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to the Last Measurable Concentration (AUClast) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 | |
| AUC from Time 0 to Infinity (AUCinf) of Rosuvastatin, Administered Alone and in Combination with RO7795081 | Periods 1 and 4: predose and postdose at prespecified times on Days 1 to 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of RO7795081 Over Time, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 | |
| Cmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP45800 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Plc (LPRA) - Netherlands | Recruiting | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Placebo | Drug | Placebo will be administered orally during Periods 3, 4, and 5, according to the protocol. |
|
| Rosuvastatin | Drug | A single 10 mg dose of rosuvastatin (ROS) will be taken on Day 1 of Period 1 and on Day 1 of Period 4. |
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| Pitavastatin | Drug | A single 1 mg dose of pitavastatin (PIT) will be taken on Day 1 of Period 2 and on Day 1 of Period 5. |
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| Cmax of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| Tmax of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| AUClast of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| AUCinf of Pitavastatin, Administered Alone and in Combination with RO7795081 | Periods 2 and 5: predose and postdose at prespecified times on Days 1 to 4 |
| Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| Tmax of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| AUClast of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| AUCinf of RO7795081, Administered Alone and in Combination with Rosuvastatin and Pitavastatin | Period 3: predose and postdose at prespecified times from Days 2 to 49; Period 4: predose and postdose at prespecified times on Days 1 to 4; Periods 4: predose and postdose at prespecified times on Days 1 to 9 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C108475 | pitavastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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