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This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Placebo (PL) | Placebo Comparator |
| |
| Part 1: Single Ascending Doses (SAD) of RO6836191 | Experimental |
| |
| Part 2: PL: Low-salt (LS) followed by normal-salt (NS) diet | Placebo Comparator |
| |
| Part 2: PL: NS followed by LS diet | Placebo Comparator |
| |
| Part 2: RO6836191: LS followed by NS diet | Experimental |
| |
| Part 2: RO6836191: NS followed by LS diet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LS followed by NS diet condition | Other | LS diet period followed by NS diet period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Area under the concentration-time curve (AUC) | Up to Day 35 | |
| Part 2: Plasma aldosterone levels | Up to 2 days after drug administration | |
| Part 2: Urine aldosterone levels | Up to 3 days after drug administration | |
| Part 1: Plasma aldosterone levels | Up to Day 5 | |
| Part 1: Urine aldosterone levels | Up to Day 3 | |
| Part 2: Incidence of AEs | Up to 12 weeks | |
| Parts 1: Incidence of adverse events (AE) | Until Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Volume of distribution after intravenous administration | Days 28-37 |
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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 |
|---|---|---|---|---|---|---|
| Marlton | New Jersey | 08053 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27872236 | Derived | Bogman K, Schwab D, Delporte ML, Palermo G, Amrein K, Mohr S, De Vera Mudry MC, Brown MJ, Ferber P. Preclinical and Early Clinical Profile of a Highly Selective and Potent Oral Inhibitor of Aldosterone Synthase (CYP11B2). Hypertension. 2017 Jan;69(1):189-196. doi: 10.1161/HYPERTENSIONAHA.116.07716. Epub 2016 Nov 21. |
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| NS followed by LS diet condition | Other | NS diet period followed by LS diet period |
|
| Placebo | Drug | Single oral administrations |
|
| Placebo | Drug | 2 single oral administrations |
|
| RO6836191 | Drug | Orally administered, single ascending doses |
|
| RO6836191 | Drug | 2 single oral doses |
|
| RO6836191 | Drug | Intravenous administration |
|
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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