Trial Outcomes & Findings for Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers (NCT NCT04729309)
NCT ID: NCT04729309
Last Updated: 2024-07-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Up to Day 17
Results posted on
2024-07-15
Participant Flow
Participant milestones
| Measure |
Absolute Bioavailability (BA) Cohort
Period 1: Participants received 600 mg of oral \[12C\] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay.
Period 2: After a 7-day washout period, participants received 1000 mg of oral \[12C\] RO7049389, followed by 100 ug of IV \[13C\] RO7049389 after a two-hour delay.
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Period 1
STARTED
|
16
|
6
|
|
Period 1
COMPLETED
|
12
|
6
|
|
Period 1
NOT COMPLETED
|
4
|
0
|
|
Period 2
STARTED
|
12
|
0
|
|
Period 2
COMPLETED
|
12
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Absolute Bioavailability (BA) Cohort
Period 1: Participants received 600 mg of oral \[12C\] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay.
Period 2: After a 7-day washout period, participants received 1000 mg of oral \[12C\] RO7049389, followed by 100 ug of IV \[13C\] RO7049389 after a two-hour delay.
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Period 1
Subject unable to return for Period 2
|
3
|
0
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Absolute Bioavailability (BA) Cohort
n=16 Participants
Period 1: Participants received 600 mg of oral \[12C\] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay.
Period 2: After a 7-day washout period, participants received 1000 mg of oral \[12C\] RO7049389, followed by 100 ug of IV \[13C\] RO7049389 after a two-hour delay.
|
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Percentage of Dose Excreted in Urine - MB Cohort
|
3.81 Percentage
Geometric Coefficient of Variation 35.2
|
—
|
PRIMARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Percentage of Dose Excreted in Feces - MB Cohort
|
90.5 Percentage
Geometric Coefficient of Variation 4.9
|
—
|
PRIMARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Percent Total Recovery (Urine + Feces) - MB Cohort
|
94.5 Percentage
Geometric Coefficient of Variation 5.5
|
—
|
PRIMARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Absolute Oral BA for RO7049389 - BA Cohort
Asian participants - Period 1
|
41.7 Percentage
Geometric Coefficient of Variation 65.3
|
—
|
|
Absolute Oral BA for RO7049389 - BA Cohort
Caucasian participants - Period 1
|
30.6 Percentage
Geometric Coefficient of Variation 45.8
|
—
|
|
Absolute Oral BA for RO7049389 - BA Cohort
Asian participants - Period 2
|
61.4 Percentage
Geometric Coefficient of Variation 90.2
|
—
|
|
Absolute Oral BA for RO7049389 - BA Cohort
Caucasian participants - Period 2
|
40.7 Percentage
Geometric Coefficient of Variation 56
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Clearance (CL) of RO7049389 - MB Cohort
[12C] RO7049389
|
100 L/h
Geometric Coefficient of Variation 71.4
|
—
|
|
Clearance (CL) of RO7049389 - MB Cohort
[13C] RO7049389
|
25.3 L/h
Geometric Coefficient of Variation 54.3
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Clearance (CL) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
36.6 L/h
Geometric Coefficient of Variation 122.3
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
75.3 L/h
Geometric Coefficient of Variation 69.2
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
14.8 L/h
Geometric Coefficient of Variation 48.2
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
21.9 L/h
Geometric Coefficient of Variation 28.7
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
37.2 L/h
Geometric Coefficient of Variation 152.1
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
87.3 L/h
Geometric Coefficient of Variation 96.5
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
14.7 L/h
Geometric Coefficient of Variation 43.9
|
—
|
|
Clearance (CL) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
24.7 L/h
Geometric Coefficient of Variation 42.3
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Half-Life (T1/2) of RO7049389 - MB Cohort
[12C] RO7049389
|
8.1 Hours
Geometric Coefficient of Variation 24.6
|
—
|
|
Half-Life (T1/2) of RO7049389 - MB Cohort
[13C] RO7049389
|
1.9 Hours
Geometric Coefficient of Variation 23.6
|
—
|
|
Half-Life (T1/2) of RO7049389 - MB Cohort
[14C] RO7049389
|
11.4 Hours
Geometric Coefficient of Variation 35.3
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
8.3 Hours
Geometric Coefficient of Variation 35.4
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
7.6 Hours
Geometric Coefficient of Variation 31.1
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
1.6 Hours
Geometric Coefficient of Variation 32.8
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
1.3 Hours
Geometric Coefficient of Variation 46.0
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
6.7 Hours
Geometric Coefficient of Variation 83.6
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
11.1 Hours
Geometric Coefficient of Variation 34.6
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
1.6 Hours
Geometric Coefficient of Variation 36.7
|
—
|
|
Half-Life (T1/2) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
1.1 Hours
Geometric Coefficient of Variation 46.7
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort
[12C] RO7049389
|
3820 ng/mL
Geometric Coefficient of Variation 144.8
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort
[13C] RO7049389
|
7.6 ng/mL
Geometric Coefficient of Variation 16.9
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - MB Cohort
[14C] RO7049389
|
6390 ng/mL
Geometric Coefficient of Variation 89.7
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
6390 ng/mL
Geometric Coefficient of Variation 118
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
3000 ng/mL
Geometric Coefficient of Variation 112.9
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
8.2 ng/mL
Geometric Coefficient of Variation 21.4
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
7.7 ng/mL
Geometric Coefficient of Variation 13.5
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
9470 ng/mL
Geometric Coefficient of Variation 110.7
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
3570 ng/mL
Geometric Coefficient of Variation 109.3
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
8.7 ng/mL
Geometric Coefficient of Variation 13.3
|
—
|
|
Maximum Plasma Concentration (Cmax) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
7.7 ng/mL
Geometric Coefficient of Variation 14.1
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort
[12C] RO7049389
|
1.50 Hours
Interval 1.0 to 2.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort
[13C] RO7049389
|
2.13 Hours
Interval 2.13 to 2.13
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - MB Cohort
[14C] RO7049389
|
4.00 Hours
Interval 1.5 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
1.75 Hours
Interval 1.5 to 2.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
2.00 Hours
Interval 1.0 to 4.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
2.13 Hours
Interval 2.13 to 2.13
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
6.00 Hours
Interval 4.0 to 8.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
1.50 Hours
Interval 1.5 to 2.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
2.00 Hours
Interval 1.0 to 4.0
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
2.13 Hours
Interval 2.13 to 2.13
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
2.13 Hours
Interval 2.13 to 2.13
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort
[13C] RO7049389
|
4.0 h*ng/mL
Geometric Coefficient of Variation 54.3
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort
[12C] RO7049389
|
5970 h*ng/mL
Geometric Coefficient of Variation 71.4
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - MB Cohort
[14C] RO7049389
|
83700 h*ng/mL
Geometric Coefficient of Variation 39.6
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
16400 h*ng/mL
Geometric Coefficient of Variation 122.3
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
7970 h*ng/mL
Geometric Coefficient of Variation 69.2
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
6.8 h*ng/mL
Geometric Coefficient of Variation 48.2
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
4.6 h*ng/mL
Geometric Coefficient of Variation 28.7
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
26900 h*ng/mL
Geometric Coefficient of Variation 152.1
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
11500 h*ng/mL
Geometric Coefficient of Variation 96.5
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
6.8 h*ng/mL
Geometric Coefficient of Variation 43.9
|
—
|
|
Area Under Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
4.1 h*ng/mL
Geometric Coefficient of Variation 42.3
|
—
|
SECONDARY outcome
Timeframe: Up to Day 17Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - MB Cohort
|
8280 h*ng/mL
Geometric Coefficient of Variation 129.7
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
16300 h*ng/mL
Geometric Coefficient of Variation 123.1
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
8110 h*ng/mL
Geometric Coefficient of Variation 63.7
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
6.5 h*ng/mL
Geometric Coefficient of Variation 45.9
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
4.4 h*ng/mL
Geometric Coefficient of Variation 27.2
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
26800 h*ng/mL
Geometric Coefficient of Variation 152.2
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
10100 h*ng/mL
Geometric Coefficient of Variation 96.9
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
7.2 h*ng/mL
Geometric Coefficient of Variation 41.1
|
—
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
4.3 h*ng/mL
Geometric Coefficient of Variation 38.1
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Apparent Clearance (CL/F) of RO7049389 - MB Cohort
|
100 L/h
Geometric Coefficient of Variation 71.4
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
36.6 L/h
Geometric Coefficient of Variation 122.3
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
75.3 L/h
Geometric Coefficient of Variation 69.2
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
37.2 L/h
Geometric Coefficient of Variation 152.1
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
87.3 L/h
Geometric Coefficient of Variation 96.5
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Asian participants - [13C] Period 1
|
14.8 L/h
Geometric Coefficient of Variation 48.2
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 1
|
21.9 L/h
Geometric Coefficient of Variation 28.7
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Asian participants - [13C] Period 2
|
14.7 L/h
Geometric Coefficient of Variation 43.9
|
—
|
|
Apparent Clearance (CL/F) of RO7049389 - BA Cohort
Caucasian participants - [13C] Period 2
|
24.7 L/h
Geometric Coefficient of Variation 42.3
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Renal Clearance (CLr) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
2.7 mL/min
Geometric Coefficient of Variation 42.6
|
—
|
|
Renal Clearance (CLr) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
1.1 mL/min
Geometric Coefficient of Variation 61.1
|
—
|
|
Renal Clearance (CLr) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
2.5 mL/min
Geometric Coefficient of Variation 22.9
|
—
|
|
Renal Clearance (CLr) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
0.8 mL/min
Geometric Coefficient of Variation 65.5
|
—
|
SECONDARY outcome
Timeframe: Up to Day 4 of Periods 1 and 2Population: All participants who have received at least one dose of study treatment and who have data from at least one post-dose sample were included in the PK analysis population. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete which may influence the PK analysis.
Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort
Asian participants - [12C] Period 1
|
3.4 mg
Standard Deviation 2.5
|
—
|
|
Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 1
|
0.8 mg
Standard Deviation 0.8
|
—
|
|
Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort
Asian participants - [12C] Period 2
|
5.9 mg
Standard Deviation 4.5
|
—
|
|
Amount Excreted in Urine (Ae) of RO7049389 - BA Cohort
Caucasian participants - [12C] Period 2
|
1.0 mg
Standard Deviation 1.2
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29 (MB Cohort) or up to Day 29 of Period 2 (AB Cohort)Outcome measures
| Measure |
Mass Balance (MB) Cohort
n=16 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
Mass Balance (MB) Cohort
n=6 Participants
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
81.3 Percentage of participants
|
33.3 Percentage of participants
|
Adverse Events
Absolute Bioavailability (BA) Cohort
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Mass Balance (MB) Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Absolute Bioavailability (BA) Cohort
n=16 participants at risk
Period 1: Participants received 600 mg of oral \[12C\] RO7049389 under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay.
Period 2: After a 7-day washout period, participants received 1000 mg of oral \[12C\] RO7049389, followed by 100 ug of IV \[13C\] RO7049389 after a two-hour delay.
|
Mass Balance (MB) Cohort
n=6 participants at risk
Participants received 600 mg of \[14C\] RO7049389 oral suspension under fasted conditions, followed by 100 ug of intravenous (IV) \[13C\] RO7049389 after a two-hour delay. (Note: \[14C\] RO7049389 was a combination of \[12C\]+\[14C\]-labeled RO7049389).
|
|---|---|---|
|
Eye disorders
Eyelid rash
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
General disorders
Catheter site pain
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
62.5%
10/16 • Number of events 10 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
33.3%
2/6 • Number of events 2 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
0.00%
0/6 • MB Cohort: From Day -1 to Day 29 of Period 1 (approximately 30 days total). BA Cohort: from Day -1 of Period 1 up to Day 29 of Period 2 (approximately 60 days total).
Safety data were analyzed by cohort rather than by period due to the well-established safety profile of RO7049389 from previous Phase 1 and Phase 2 studies. There was no difference in population in the BA cohort between Periods 1 and 2 and AEs were collected irrespective of intervention within the cohort.
|
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