Healthy VolunteersPhase 1NCT03774576

A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

A Phase 1 study testing RO7017773 and Itraconazole in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: RO7017773 and Itraconazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteFrance
Study dates: 17 Dec 2018to 14 Mar 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator.
Male and women of non-childbearing potential (WONCBP)

Who cannot join

History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)
History of clinically significant hypersensitivity or allergic reactions
Abnormal blood pressure
Abnormal pulse rate
History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
Current or chronic history of liver disease, or known hepatic or biliary abnormalities

Show all 10Show fewer

Positive test for drugs of abuse or alcohol
Evidence of human immunodeficiency virus (HIV) infection
Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment
Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period

Trial locations and contacts

1 site in 1 country.

France1 site

BIOTRIAL
Rennes, 35042

Other trials in France

About this study

Official title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

Conditions: Healthy Volunteers
Being tested: RO7017773, Itraconazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7017773Drug
Single doses of RO7017773
ItraconazoleDrug
Also called Sporanox
Multiple doses of Itraconazole

Study groups in NCT03774576
Study group	Role	What they receive
RO7017773	Experimental	Single dose of RO7017773 Receives: Drug: RO7017773
RO7017773 and Itraconazole	Experimental	Single dose of RO7017773 and multiple doses of itraconazole Receives: Drug: RO7017773; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration (Cmax) of RO7017773 in Plasma
Measured: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)

Secondary outcomes (3)

Percentage of Participants With Adverse Events (AEs)
Measured: 12 weeks
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Measured: From screening visit through Period 2 Day 11
Cmax of Itraconazole in Plasma
Measured: Period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201814 Mar 2019

First posted13 Dec 2018
Study start17 Dec 2018
Primary completion14 Mar 2019
Study completion14 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03774576
Sponsor's protocol ID: BP40822
Other IDs: 2018-002889-40, 2018
Status last verified: Apr 2020
First submitted: 11 Dec 2018
Last updated: 7 May 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
ClinicalTrials.gov ID: NCT03774576
Acronym / sponsor ID: BP40822
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 17 Dec 2018 (actual)
Primary completion: 14 Mar 2019 (actual)
Study completion: 14 Mar 2019 (actual)
First posted: 13 Dec 2018 (actual)
Results: Posted 7 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RO7017773	Experimental	Drug: RO7017773Single dose of RO7017773
RO7017773 and Itraconazole	Experimental	Drug: RO7017773, Drug: ItraconazoleSingle dose of RO7017773 and multiple doses of itraconazole

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator.
Male and women of non-childbearing potential (WONCBP)

Key exclusion criteria (10 listed)

History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)
History of clinically significant hypersensitivity or allergic reactions
Abnormal blood pressure
Abnormal pulse rate
History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RO7017773Single doses of RO7017773	Drug	RO7017773, RO7017773 and Itraconazole
ItraconazoleAlso: SporanoxMultiple doses of Itraconazole	Drug	RO7017773 and Itraconazole

Primary outcome

Maximum Concentration (Cmax) of RO7017773 in Plasma
Time frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)

3 secondary outcomes

Percentage of Participants With Adverse Events (AEs)
Time frame: 12 weeks
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: From screening visit through Period 2 Day 11
Cmax of Itraconazole in Plasma
Time frame: Period 2

Results and safety

Results posted to the registry on 7 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RO7017773 Alone, Then RO7017773 + Itraconazole	14	14

Primary outcome: Maximum Concentration (Cmax) of RO7017773 in Plasma

Time frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	RO7017773 Alone n = 13	RO7017773 + Itraconazole n = 13
Value	458 (32.1)	516 (22.7)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RO7017773 Alone	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14
Itraconazole Alone	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
RO7017773 + Itraconazole	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7017773 and Itraconazole in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Concentration (Cmax) of RO7017773 in Plasma (time frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03774576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.