Trial Outcomes & Findings for A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants (NCT NCT03570658)
NCT ID: NCT03570658
Last Updated: 2020-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
From the date of first administered dose through 28 days after the last administered dose.
Results posted on
2020-02-28
Participant Flow
Healthy male Chinese subjects aged 18-60 years.
Total n=31. SAD n=28 (Active treatment n=22 and placebo n=6). 21 participants continued on to the MAD phase of the study. 3 participants chose not to continue. MAD n=24. 3 participants were directly enrolled into the MAD phase of the study in addition to the 21 participants from the SAD phase.
Participant milestones
| Measure |
Placebo
Participants in both the MAD and SAD cohorts received placebo matched to RO7049389.
|
RO7049389 - 200 mg
Participants in the SAD cohort received a single 200 mg dose of RO7049389.
|
RO7049389 - 400 mg/200 mg q12h
Participants in the SAD cohort received a single 400 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 400 mg single dose received 200 mg of RO7049389 every 12 hours (q12h) for 14 days.
|
RO7049389 - 600 mg/400 mg q12h
Participants in the SAD cohort only received a single 600 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 q12h for 14 days.
|
|---|---|---|---|---|
|
Single Ascending Dose (SAD)
STARTED
|
6
|
2
|
10
|
10
|
|
Single Ascending Dose (SAD)
COMPLETED
|
6
|
2
|
10
|
10
|
|
Single Ascending Dose (SAD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Multiple Ascending Dose (MAD)
STARTED
|
4
|
0
|
10
|
10
|
|
Multiple Ascending Dose (MAD)
COMPLETED
|
4
|
0
|
10
|
10
|
|
Multiple Ascending Dose (MAD)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The SAD population included 28 participants assigned to either placebo or active treatment.
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants in both the MAD and SAD cohorts received placebo matched to RO7049389.
|
RO7049389 - 200 mg
n=2 Participants
Participants in the SAD cohort received a single 200 mg dose of RO7049389.
|
RO7049389 - 400 mg/200 mg q12h
n=12 Participants
Participants in the SAD cohort received a single 400 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 400 mg single dose received 200 mg of RO7049389 every 12 hours (q12h) for 14 days.
|
RO7049389 - 600 mg/400 mg q12h
n=11 Participants
Participants in the SAD cohort only received a single 600 mg dose of RO7049389. Participants in the MAD cohort that formerly received the 600 mg single dose received 400 mg of RO7049389 q12h for 14 days.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.8 Years
STANDARD_DEVIATION 6.1 • n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
33.5 Years
STANDARD_DEVIATION 6.4 • n=2 Participants • The SAD population included 28 participants assigned to either placebo or active treatment.
|
31.1 Years
STANDARD_DEVIATION 3.3 • n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
29.0 Years
STANDARD_DEVIATION 6.5 • n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
29.8 Years
STANDARD_DEVIATION 5.2 • n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
2 Participants
n=2 Participants • The SAD population included 28 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
24 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
24 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
10 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
24 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=10 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
0 Participants
n=24 Participants • The MAD population included 24 participants assigned to either placebo or active treatment.
|
PRIMARY outcome
Timeframe: From the date of first administered dose through 28 days after the last administered dose.Population: 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.
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.
Outcome measures
| Measure |
SAD - Placebo
n=6 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=2 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=4 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
n=10 Participants
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
n=10 Participants
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
30.0 Percentage of Participants
|
10.0 Percentage of Participants
|
50.0 Percentage of Participants
|
90.0 Percentage of Participants
|
60.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)Population: PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of RO7049389
Day 1
|
3840 ng/mL
Geometric Coefficient of Variation 41.3
|
5220 ng/mL
Geometric Coefficient of Variation 84.8
|
4020 ng/mL
Geometric Coefficient of Variation 116
|
3230 ng/mL
Geometric Coefficient of Variation 40.6
|
9210 ng/mL
Geometric Coefficient of Variation 51.1
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of RO7049389
Day 14
|
—
|
—
|
—
|
2730 ng/mL
Geometric Coefficient of Variation 35.4
|
8030 ng/mL
Geometric Coefficient of Variation 60.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)Population: PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389
Day 1
|
1.5 Hours (h)
Interval 1.5 to 1.5
|
1.5 Hours (h)
Interval 1.0 to 3.0
|
2 Hours (h)
Interval 1.0 to 4.0
|
1.5 Hours (h)
Interval 1.5 to 2.0
|
2 Hours (h)
Interval 1.0 to 3.0
|
—
|
—
|
|
Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389
Day 14
|
—
|
—
|
—
|
2 Hours (h)
Interval 1.5 to 2.02
|
2 Hours (h)
Interval 1.5 to 3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)Population: PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389
Day 1
|
5960 h*ng/mL
Geometric Coefficient of Variation 60.9
|
12200 h*ng/mL
Geometric Coefficient of Variation 85.1
|
10800 h*ng/mL
Geometric Coefficient of Variation 121
|
5090 h*ng/mL
Geometric Coefficient of Variation 38
|
19400 h*ng/mL
Geometric Coefficient of Variation 72.6
|
—
|
—
|
|
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389
Day 14
|
—
|
—
|
—
|
5460 h*ng/mL
Geometric Coefficient of Variation 29.2
|
20900 h*ng/mL
Geometric Coefficient of Variation 90.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)Population: PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)
Day 1
|
9460 h*ng/mL
Geometric Coefficient of Variation NA
NA = there was only one participant sample.
|
12300 h*ng/mL
Geometric Coefficient of Variation 84.6
|
11100 h*ng/mL
Geometric Coefficient of Variation 120
|
5180 h*ng/mL
Geometric Coefficient of Variation 37.7
|
19500 h*ng/mL
Geometric Coefficient of Variation 72.7
|
—
|
—
|
|
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)
Day 14
|
—
|
—
|
—
|
5470 h*ng/mL
Geometric Coefficient of Variation 29.1
|
20900 h*ng/mL
Geometric Coefficient of Variation 90.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)Population: PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 Participants
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Apparent Half-Life (T1/2) of RO7049389
Day 1
|
3.66 Hours (h)
Geometric Coefficient of Variation 0
|
7.98 Hours (h)
Geometric Coefficient of Variation 97.8
|
10.4 Hours (h)
Geometric Coefficient of Variation 108
|
2.29 Hours (h)
Geometric Coefficient of Variation 39.4
|
1.62 Hours (h)
Geometric Coefficient of Variation 33.1
|
—
|
—
|
|
Apparent Half-Life (T1/2) of RO7049389
Day 14
|
—
|
—
|
—
|
5.06 Hours (h)
Geometric Coefficient of Variation 31.6
|
6.74 Hours (h)
Geometric Coefficient of Variation 36.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 1 (SAD)Population: This parameter was not collected for the MAD cohort.
Outcome measures
| Measure |
SAD - Placebo
n=2 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 Participants
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Clearance (CL/F) of RO7049389
|
21.1 L/h
Geometric Coefficient of Variation 0
|
32.6 L/h
Geometric Coefficient of Variation 58.2
|
53.9 L/h
Geometric Coefficient of Variation 61.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 14 (MAD)Population: This outcome measure applied to arms receiving RO7049389 during the MAD phase.
Outcome measures
| Measure |
SAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of RO7049389
|
31.1 ng/mL
Geometric Coefficient of Variation 29.8
|
66.1 ng/mL
Geometric Coefficient of Variation 133
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 14 (MAD)Population: This parameter was not collected for SAD cohorts.
Outcome measures
| Measure |
SAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Index of RO7049389
MAD Cohorts - Day 14 Cmax
|
0.846 Ratio
Geometric Coefficient of Variation 76.9
|
0.872 Ratio
Geometric Coefficient of Variation 41.7
|
—
|
—
|
—
|
—
|
—
|
|
Accumulation Index of RO7049389
MAD Cohorts - Day 14 AUC
|
1.03 Ratio
Geometric Coefficient of Variation 47
|
1.05 Ratio
Geometric Coefficient of Variation 37.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-defined intervals on Day 14 (MAD)Population: This parameter was not collected for SAD cohorts.
Outcome measures
| Measure |
SAD - Placebo
n=10 Participants
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=10 Participants
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
Participants received placebo matched to RO7049389.
|
MAD RO7049389 - 200 mg
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)
MAD Cohorts - Day 1
|
5090 h*ng/mL
Geometric Coefficient of Variation 38
|
19400 h*ng/mL
Geometric Coefficient of Variation 72.6
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)
MAD Cohorts - Day 14
|
5230 h*ng/mL
Geometric Coefficient of Variation 29.7
|
20400 h*ng/mL
Geometric Coefficient of Variation 90.7
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD RO7049389 - 200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD RO7049389 - 400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD RO7049389 - 600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD - Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD RO7049389 - 200 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MAD RO7049389 - 400 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD - Placebo
n=6 participants at risk
Participants received placebo matched to RO7049389.
|
SAD RO7049389 - 200 mg
n=2 participants at risk
Participants received a single 200 mg dose of RO7049389.
|
SAD RO7049389 - 400 mg
n=10 participants at risk
Participants received a single 400 mg dose of RO7049389.
|
SAD RO7049389 - 600 mg
n=10 participants at risk
Participants received a single 600 mg dose of RO7049389.
|
MAD - Placebo
n=4 participants at risk
Participants received placebo matched to RO7049389
|
MAD RO7049389 - 200 mg
n=10 participants at risk
Participants received 200 mg of RO7049389 every 12 hours for 14 days.
|
MAD RO7049389 - 400 mg
n=10 participants at risk
Participants received 400 mg of RO7049389 every 12 hours for 14 days.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
20.0%
2/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Eosinophil percentage increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
20.0%
2/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
25.0%
1/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Blood uric acid increased
|
16.7%
1/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Urinary casts present
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
25.0%
1/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
50.0%
2/4 • From the date of first administered dose through 28 days after the last administered dose.
|
80.0%
8/10 • From the date of first administered dose through 28 days after the last administered dose.
|
30.0%
3/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/2 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/4 • From the date of first administered dose through 28 days after the last administered dose.
|
10.0%
1/10 • From the date of first administered dose through 28 days after the last administered dose.
|
0.00%
0/10 • From the date of first administered dose through 28 days after the last administered dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER