Healthy Participants
Conditions
Brief summary
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
Interventions
DRUGRO7062931
RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.
DRUGPlacebo
Matching placebo will be administered subcutaneously (SC).
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Chinese healthy male and female (of non-childbearing potential) volunteers. * A Body Mass Index (BMI) between 19 to 27 kilogram per square meter (kg/m2) inclusive and a body weight of at least 45 kg. * Women should be of non-childbearing potential. These include those who have undergone surgical sterilization (removal of ovaries and/or uterus) or are post-menopausal. * Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose of RO7062931, and agree to refrain from donating sperm during this same period. * Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.
Exclusion criteria
* History of drug or alcohol abuse or dependence in previous 6 months. * Positive urine drug and alcohol screen or positive cotinine test at Screening or Day -1. * Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV)-1 and -2 at Screening. * Confirmed blood pressure or resting pulse rate outside of accepted ranges. * Participation in an investigational drug or device study within 90 days prior to screening. * Donation of blood over 500 milliliters (mL) within three months prior to screening. * Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit. * Alcohol consumption of more than 2 standard drinks per day on average. * Screening or baseline ECG evidence of atrial fibrillation, atrial flutter, complete right or left bundle branch block, Wolff-Parkinson-White syndrome, or cardiac pacemaker. * Any out of range findings in liver function tests, INR and renal function tests or any clinically significant abnormalities (as judged by the Investigator) in the physical examination and in the remaining laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) at Screening or on Day-1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events and AEs of Special Interest | Up to 16 weeks | Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events |
| Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Baseline, Day 2, 8, 15, 29, 85 | Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities. |
| Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. |
| Percentage of Participants With T-wave Abnormalities | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. |
| Percentage of Participants With U-wave Abnormalities | Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85 | Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Clearance (CL/F) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Apparent oral clearance was calculated from Dose/AUCinf. |
| Apparent Volume of Distribution (Vz/F) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Apparent volume of distribution was calculated from Dose/AUCinf |
| Maximum Plasma Concentration (Cmax) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931 |
| Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | 0-24h h post-dose Day 1 | The fraction of cumulative amount in urine were calculated based on Ae/Dose |
| Cumulative Amount of RO7062931 Excreted in Urine (Ae) | (0-4), (4-8), (8-12), (12-24)h post-dose Day 1 | Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected. |
| Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis. |
| Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis |
| Terminal Elimination Half-Life (t1/2) for RO7062931 | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8 | Terminal Half-life was calculated based on Non-Compartment Analysis. |
Countries
Hong Kong
Participant flow
Recruitment details
Planned: Up to 50 healthy volunteers (HVs) across 5 cohorts of 10 HVs (8 active, 2 placebo) per dose-level. Actual: A total of 41 HVs were enrolled across 4 dose cohorts.
Participants by arm
| Arm | Count |
|---|---|
| RO7062931 0.3mg/kg Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931. | 9 |
| RO7062931 1.0mg/kg Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931. | 8 |
| RO7062931 2.0mg/kg Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931. | 8 |
| RO7062931 4.0mg/kg Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931. | 8 |
| Placebo Participants will receive matching placebo. | 8 |
| Total | 41 |
Baseline characteristics
| Characteristic | RO7062931 4.0mg/kg | Placebo | Total | RO7062931 0.3mg/kg | RO7062931 1.0mg/kg | RO7062931 2.0mg/kg |
|---|---|---|---|---|---|---|
| Age, Continuous | 29.6 Years STANDARD_DEVIATION 9.2 | 34.5 Years | 30.2 Years STANDARD_DEVIATION 10.7 | 28.8 Years STANDARD_DEVIATION 6.4 | 29.3 Years STANDARD_DEVIATION 11.5 | 29.8 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 41 Participants | 9 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/ Chinese | 8 Participants | 8 Participants | 41 Participants | 9 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 41 Participants | 9 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 6 / 9 | 5 / 8 | 5 / 8 | 6 / 8 | 7 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Percentage of Participants With Adverse Events and AEs of Special Interest
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
Time frame: Up to 16 weeks
Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO7062931 0.3mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events of Special interest (AESI) | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events | 66.7 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events | 62.5 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events of Special interest (AESI) | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events | 62.5 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events of Special interest (AESI) | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events | 75.0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events of Special interest (AESI) | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events of Special interest (AESI) | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Adverse Events and AEs of Special Interest | Adverse Events | 87.5 Percentage of Participants |
Primary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration Low | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula Low | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate Low | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration Low | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate High | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration High | 25.0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration High | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration High | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula Low | 12.5 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula Low | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration Low | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration Low | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration Low | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate Low | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate Low | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration Low | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula Low | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration Low | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration High | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QRS Duration High | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTcF - Fridericia's Correction Formula High | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QT Duration High | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | PR Duration Low | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart Rate High | 0 Percentage of Participants |
Primary
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Time frame: Baseline, Day 2, 8, 15, 29, 85
Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO7062931 0.3mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST High | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Triglycerides High | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Abs, Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Abs, Low | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST High | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Triglycerides High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Abs, Low | 12.5 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST High | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Triglycerides High | 12.5 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Triglycerides High | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Abs, Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Neutrophils, Total, Abs, Low | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | SGOT/AST High | 0 Percentage of Participants |
| Placebo | Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results | Triglycerides High | 12.5 Percentage of Participants |
Primary
Percentage of Participants With T-wave Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With T-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With T-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
Primary
Percentage of Participants With U-wave Abnormalities
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Time frame: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 4H | 22.2 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 85 | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 8H | 22.2 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 15 | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 1H | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Baseline Normal | 22.2 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 8 / 168H | 12.5 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 2 / 24H | 11.1 Percentage of Participants |
| RO7062931 0.3mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 12H | 22.2 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 1.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| RO7062931 2.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 1H | 25.0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 85 | 12.5 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Baseline Normal | 25.0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 4H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 2 / 24H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 15 | 12.5 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 8 / 168H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 8H | 0 Percentage of Participants |
| RO7062931 4.0mg/kg | Percentage of Participants With U-wave Abnormalities | Day 1 / 12H | 0 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 1 / 8H | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 29 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 1 / 12H | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 2 / 24H | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 85 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 8 / 168H | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Baseline Normal | 0 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Follow-up Visit Day 15 | 0 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 1 / 4H | 12.5 Percentage of Participants |
| Placebo | Percentage of Participants With U-wave Abnormalities | Day 1 / 1H | 0 Percentage of Participants |
Secondary
Apparent Clearance (CL/F) for RO7062931
Apparent oral clearance was calculated from Dose/AUCinf.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Apparent Clearance (CL/F) for RO7062931 | 29.24 L/h | Geometric Coefficient of Variation 11.4 |
| RO7062931 1.0mg/kg | Apparent Clearance (CL/F) for RO7062931 | 27.23 L/h | Geometric Coefficient of Variation 18.8 |
| RO7062931 2.0mg/kg | Apparent Clearance (CL/F) for RO7062931 | 25.24 L/h | Geometric Coefficient of Variation 18.5 |
| RO7062931 4.0mg/kg | Apparent Clearance (CL/F) for RO7062931 | 17.46 L/h | Geometric Coefficient of Variation 8.4 |
Secondary
Apparent Volume of Distribution (Vz/F) for RO7062931
Apparent volume of distribution was calculated from Dose/AUCinf
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Apparent Volume of Distribution (Vz/F) for RO7062931 | 163.27 L | Geometric Coefficient of Variation 45.7 |
| RO7062931 1.0mg/kg | Apparent Volume of Distribution (Vz/F) for RO7062931 | 2616.31 L | Geometric Coefficient of Variation 35.8 |
| RO7062931 2.0mg/kg | Apparent Volume of Distribution (Vz/F) for RO7062931 | 2980.22 L | Geometric Coefficient of Variation 40 |
| RO7062931 4.0mg/kg | Apparent Volume of Distribution (Vz/F) for RO7062931 | 2235.97 L | Geometric Coefficient of Variation 15.3 |
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931
Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | 95.26 h*nmol/L | Geometric Coefficient of Variation 9 |
| RO7062931 1.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | 349.75 h*nmol/L | Geometric Coefficient of Variation 14.8 |
| RO7062931 2.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | 791.99 h*nmol/L | Geometric Coefficient of Variation 19.9 |
| RO7062931 4.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931 | 2180.74 h*nmol/L | Geometric Coefficient of Variation 8.3 |
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931
Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | 95.16 h*nmol/L | Geometric Coefficient of Variation 9 |
| RO7062931 1.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | 348.33 h*nmol/L | Geometric Coefficient of Variation 14.8 |
| RO7062931 2.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | 786.33 h*nmol/L | Geometric Coefficient of Variation 20.8 |
| RO7062931 4.0mg/kg | Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931 | 2114.90 h*nmol/L | Geometric Coefficient of Variation 10.9 |
Secondary
Cumulative Amount of RO7062931 Excreted in Urine (Ae)
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Time frame: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RO7062931 0.3mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-8h | 35.35 nmol | Standard Deviation 6.64 |
| RO7062931 0.3mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-24h | 41.88 nmol | Standard Deviation 6.69 |
| RO7062931 1.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-24h | 147.88 nmol | Standard Deviation 40.78 |
| RO7062931 1.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-8h | 133.79 nmol | Standard Deviation 29.09 |
| RO7062931 2.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-24h | 545.61 nmol | Standard Deviation 139.56 |
| RO7062931 2.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-8h | 326.90 nmol | Standard Deviation 106.77 |
| RO7062931 4.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-24h | 1977.71 nmol | Standard Deviation 513.27 |
| RO7062931 4.0mg/kg | Cumulative Amount of RO7062931 Excreted in Urine (Ae) | Ae 0-8h | 1433.92 nmol | Standard Deviation 595.77 |
Secondary
Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)
The fraction of cumulative amount in urine were calculated based on Ae/Dose
Time frame: 0-24h h post-dose Day 1
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | 1.50 Percentage | Standard Deviation 0.2 |
| RO7062931 1.0mg/kg | Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | 1.63 Percentage | Standard Deviation 0.3 |
| RO7062931 2.0mg/kg | Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | 2.79 Percentage | Standard Deviation 0.72 |
| RO7062931 4.0mg/kg | Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe) | 5.26 Percentage | Standard Deviation 1.65 |
Secondary
Maximum Plasma Concentration (Cmax) for RO7062931
Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Maximum Plasma Concentration (Cmax) for RO7062931 | 17.71 nmol/L | Geometric Coefficient of Variation 39.5 |
| RO7062931 1.0mg/kg | Maximum Plasma Concentration (Cmax) for RO7062931 | 57.09 nmol/L | Geometric Coefficient of Variation 28.8 |
| RO7062931 2.0mg/kg | Maximum Plasma Concentration (Cmax) for RO7062931 | 113.52 nmol/L | Geometric Coefficient of Variation 40.3 |
| RO7062931 4.0mg/kg | Maximum Plasma Concentration (Cmax) for RO7062931 | 299.39 nmol/L | Geometric Coefficient of Variation 36.5 |
Secondary
Terminal Elimination Half-Life (t1/2) for RO7062931
Terminal Half-life was calculated based on Non-Compartment Analysis.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RO7062931 0.3mg/kg | Terminal Elimination Half-Life (t1/2) for RO7062931 | 3.87 h | Geometric Coefficient of Variation 44.6 |
| RO7062931 1.0mg/kg | Terminal Elimination Half-Life (t1/2) for RO7062931 | 66.59 h | Geometric Coefficient of Variation 38.6 |
| RO7062931 2.0mg/kg | Terminal Elimination Half-Life (t1/2) for RO7062931 | 81.83 h | Geometric Coefficient of Variation 24 |
| RO7062931 4.0mg/kg | Terminal Elimination Half-Life (t1/2) for RO7062931 | 88.78 h | Geometric Coefficient of Variation 18.4 |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931
Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8
Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RO7062931 0.3mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | 1.50 h |
| RO7062931 1.0mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | 2.38 h |
| RO7062931 2.0mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | 2.87 h |
| RO7062931 4.0mg/kg | Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931 | 2.85 h |