| Primary | Percentage of Participants With Adverse Events | 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. | All safety analyses were based on the safety analysis population, which included all subjects that received at least one dose of study medication (RO7049389 or placebo), with at least one safety assessment. | Posted | | Number | | Percentage of Participants | | From the date of first administered dose through 28 days after the last administered dose. | | | | ID | Title | Description |
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| OG000 | SAD - Placebo | Participants received placebo matched to RO7049389. | | OG001 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG003 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG004 | MAD - Placebo | Participants received placebo matched to RO7049389. | | OG005 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG006 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00016.7
- OG0010
- OG00230.0
- OG003
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of RO7049389 | | PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG003 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG004 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389 | | PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms. | Posted | | Median | Full Range | Hours (h) | | At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG003 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG004 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389 | | PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG003 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG004 | MAD RO7049389 - 400 mg | |
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| Secondary | Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf) | | PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG003 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG004 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Apparent Half-Life (T1/2) of RO7049389 | | PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours (h) | | At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. | | OG003 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG004 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Clearance (CL/F) of RO7049389 | | This parameter was not collected for the MAD cohort. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | At pre-defined intervals on Day 1 (SAD) | | | | ID | Title | Description |
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| OG000 | SAD RO7049389 - 200 mg | Participants received a single 200 mg dose of RO7049389. | | OG001 | SAD RO7049389 - 400 mg | Participants received a single 400 mg dose of RO7049389. | | OG002 | SAD RO7049389 - 600 mg | Participants received a single 600 mg dose of RO7049389. |
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| Secondary | Trough Plasma Concentration (Ctrough) of RO7049389 | | This outcome measure applied to arms receiving RO7049389 during the MAD phase. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | At pre-defined intervals on Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG001 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Accumulation Index of RO7049389 | | This parameter was not collected for SAD cohorts. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | At pre-defined intervals on Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG001 | MAD RO7049389 - 400 mg | Participants received 400 mg of RO7049389 every 12 hours for 14 days. |
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| Secondary | Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau) | | This parameter was not collected for SAD cohorts. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | At pre-defined intervals on Day 14 (MAD) | | | | ID | Title | Description |
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| OG000 | MAD RO7049389 - 200 mg | Participants received 200 mg of RO7049389 every 12 hours for 14 days. | | OG001 | RO7049389 - 400 mg | Participants in the SAD cohort received a single 400 mg dose of RO7049389, followed by a 1-week washout period. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 every 12 hours for 14 days. |
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