Trial Outcomes & Findings for Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513 (NCT NCT03507569)
NCT ID: NCT03507569
Last Updated: 2019-09-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Baseline up to 48 hours (hrs)
Results posted on
2019-09-30
Participant Flow
Healthy subjects between the ages of 23 and 55 years (inclusive) were enrolled at one site in the United Kingdom.
Participant milestones
| Measure |
RO7017773 - 15mg
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 30mg
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 75mg
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 375mg
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
Baseline characteristics by cohort
| Measure |
RO7017773 - 15mg
n=2 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 30mg
n=1 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 75mg
n=2 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 375mg
n=1 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
|
PRIMARY outcome
Timeframe: Baseline up to 48 hours (hrs)Population: This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to 48 hrsPopulation: This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment initiation until 14 days after the last dose of study treatment.Outcome measures
| Measure |
RO7017773 - 15mg
n=2 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 30mg
n=1 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 75mg
n=2 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 375mg
n=1 Participants
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
RO7017773 - 15mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RO7017773 - 30mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RO7017773 - 75mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RO7017773 - 375mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RO7017773 - 15mg
n=2 participants at risk
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 30mg
n=1 participants at risk
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 75mg
n=2 participants at risk
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
RO7017773 - 375mg
n=1 participants at risk
Healthy participants received a single oral dose of RO7017773, and up to 3 intravenous (IV) doses of the radiolabeled ligand \[11C\]Ro15-4513 administered prior to positron emission tomography/computed tomography (PET/CT) scans over two imaging sessions separated by at least 7 days.
|
|---|---|---|---|---|
|
General disorders
Catheter site pain
|
100.0%
2/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
General disorders
Catheter site paraesthesia
|
50.0%
1/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
50.0%
1/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
General disorders
Catheter site bruise
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
100.0%
1/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
100.0%
1/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
0.00%
0/2 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
100.0%
1/1 • From treatment initiation until 14 days after the last dose of study treatment.
All participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not, were included in the safety analysis.
|
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