Trial Outcomes & Findings for A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants (NCT NCT03774576)
NCT ID: NCT03774576
Last Updated: 2020-05-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)
Results posted on
2020-05-07
Participant Flow
Healthy male and female participants between 18 and 55 years old. Female participants were women of non-childbearing potential (WONCBP).
Participant milestones
| Measure |
RO7017773 Alone, Then RO7017773 + Itraconazole
In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|
|
Period 1
STARTED
|
14
|
|
Period 1
COMPLETED
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
14
|
|
Period 2
COMPLETED
|
13
|
|
Period 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RO7017773 Alone, Then RO7017773 + Itraconazole
In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|
|
Period 2
Adverse Event
|
1
|
Baseline Characteristics
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Baseline characteristics by cohort
| Measure |
RO7017773 Alone, Then RO7017773 + Itraconazole
n=14 Participants
In Period 1, participants received a single dose of RO7017773 alone in a fed state. In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)Population: The pharmacokinetic set (PKS) included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. This outcome measure is specific to the reported arms.
Outcome measures
| Measure |
RO7017773 Alone
n=13 Participants
In Period 1, participants received a single dose of RO7017773 alone in a fed state.
|
RO7017773 + Itraconazole
n=13 Participants
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
RO7017773 + Itraconazole
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of RO7017773 in Plasma
|
458 ng/mL
Geometric Coefficient of Variation 32.1
|
516 ng/mL
Geometric Coefficient of Variation 22.7
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The safety set (SS) included all participants who received at least one dose of study treatment and included any participant(s) that were withdrawn from the study.
Outcome measures
| Measure |
RO7017773 Alone
n=14 Participants
In Period 1, participants received a single dose of RO7017773 alone in a fed state.
|
RO7017773 + Itraconazole
n=14 Participants
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
RO7017773 + Itraconazole
n=13 Participants
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
57.1 Percentage of Participants
|
14.3 Percentage of Participants
|
53.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: From screening visit through Period 2 Day 11Population: The included set (IS) contained all study participants.
The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present.
Outcome measures
| Measure |
RO7017773 Alone
n=14 Participants
In Period 1, participants received a single dose of RO7017773 alone in a fed state.
|
RO7017773 + Itraconazole
n=13 Participants
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
RO7017773 + Itraconazole
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|---|---|
|
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Screening
|
0 Units on a scale
Standard Deviation 0
|
0 Units on a scale
Standard Deviation 0
|
—
|
|
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 2 Day 11
|
0 Units on a scale
Standard Deviation 0
|
0 Units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Period 2Population: The pharmacokinetic set (PKS) included all participants who received at least one dose of study treatment and who had data from at least one post-dose sample. This outcome measure is specific to the reported arm.
Outcome measures
| Measure |
RO7017773 Alone
n=13 Participants
In Period 1, participants received a single dose of RO7017773 alone in a fed state.
|
RO7017773 + Itraconazole
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
RO7017773 + Itraconazole
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|---|---|
|
Cmax of Itraconazole in Plasma
|
724 ng/mL
Geometric Coefficient of Variation 43.2
|
—
|
—
|
Adverse Events
RO7017773 Alone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Itraconazole Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RO7017773 + Itraconazole
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RO7017773 Alone
n=14 participants at risk
In Period 1, participants received a single dose of RO7017773 alone in a fed state.
|
Itraconazole Alone
n=14 participants at risk
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
RO7017773 + Itraconazole
n=13 participants at risk
In Period 2, participants received a single dose of RO7017773 after repeated doses of itraconazole in a fed state.
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
30.8%
4/13 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Number of events 3 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/14 • 12 weeks
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
7.7%
1/13 • Number of events 1 • 12 weeks
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/14 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • 12 weeks
|
7.1%
1/14 • Number of events 1 • 12 weeks
|
0.00%
0/13 • 12 weeks
|
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