Healthy VolunteersPhase 1NCT03847987

A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

A Phase 1 study testing RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored and RO7017773 Phase II Tablet Sweetened/Flavored in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in United States.

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

This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring. 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 Phase I Capsule, RO7017773 Phase II Tablet Unflavored and RO7017773 Phase II Tablet Sweetened/Flavored
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2019to 22 Apr 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

Non-smoker for at least six months
Healthy, as judged by the Investigator
Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug

Who cannot join

History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing
Participation in an investigational drug or device study within 90 days prior to screening
Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

PRA Health Sciences
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants

Conditions: Healthy Volunteers
Being tested: RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored, RO7017773 Phase II Tablet Sweetened/Flavored

What participants receive

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

RO7017773 Phase I CapsuleDrug
Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.
RO7017773 Phase II Tablet UnflavoredDrug
Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.
RO7017773 Phase II Tablet Sweetened/FlavoredDrug
Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

Study groups in NCT03847987
Study group	Role	What they receive
Part 1	Experimental	Participants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses. Receives: Drug: RO7017773 Phase I Capsule; Drug: RO7017773 Phase II Tablet Unflavored
Part 2	Experimental	Participants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses. Receives: Drug: RO7017773 Phase II Tablet Unflavored; Drug: RO7017773 Phase II Tablet Sweetened/Flavored

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Measured: Day 1 to Day 5
Cmax of RO7017773 (Part 2)
Measured: Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.
Measured: Day 1

Secondary outcomes (2)

Taste Assessment, as Measured by Taste Questionnaire (Part 1)
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.
Measured: Day 1
Percentage of Participants With Adverse Events (AEs)
Measured: Baseline through end of study (approximately 6 weeks)

Timeline

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

12 Mar 201922 Apr 2019

First posted20 Feb 2019
Study start12 Mar 2019
Primary completion22 Apr 2019
Study completion22 Apr 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03847987
Sponsor's protocol ID: BP40950
Status last verified: May 2020
First submitted: 19 Feb 2019
Last updated: 28 May 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants
ClinicalTrials.gov ID: NCT03847987
Acronym / sponsor ID: BP40950
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 12 Mar 2019 (actual)
Primary completion: 22 Apr 2019 (actual)
Study completion: 22 Apr 2019 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 28 May 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part 1	Experimental	Drug: RO7017773 Phase I Capsule, Drug: RO7017773 Phase II Tablet UnflavoredParticipants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses.
Part 2	Experimental	Drug: RO7017773 Phase II Tablet Unflavored, Drug: RO7017773 Phase II Tablet Sweetened/FlavoredParticipants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses.

Who may qualify

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

Key inclusion criteria (4 listed)

Non-smoker for at least six months
Healthy, as judged by the Investigator
Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug

Key exclusion criteria (8 listed)

History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing

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
RO7017773 Phase I CapsuleParticipants will receive 1 single oral dose of RO7017773 Phase I Capsule.	Drug	Part 1
RO7017773 Phase II Tablet UnflavoredParticipants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.	Drug	Part 1, Part 2
RO7017773 Phase II Tablet Sweetened/FlavoredParticipants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.	Drug	Part 2

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Time frame: Day 1 to Day 5
Cmax of RO7017773 (Part 2)
Time frame: Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)
Time frame: Day 1
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.

2 secondary outcomes

Taste Assessment, as Measured by Taste Questionnaire (Part 1)
Time frame: Day 1
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline through end of study (approximately 6 weeks)

Results and safety

Results posted to the registry on 28 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
Part 1	16	13
Part 2	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)

Time frame: Day 1 to Day 5. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Part 1 - Treatment A n = 16	Part 1 - Treatment B n = 16	Part 1 - Treatment C n = 16	Part 1 - Treatment D n = 16
Value	1320 (25.8)	1570 (27.4)	1120 (25.3)	1490 (26.6)

Population analysed: The PK population included all participants.

Primary outcome: Cmax of RO7017773 (Part 2)

Time frame: Day 1 to Day 5. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Part 2 - Treatment A n = 8	Part 2 - Treatment B n = 8
Value	1470 (25.2)	1210 (19.0)

Primary outcome: Taste Assessment, as Measured by Taste Questionnaire (Part 2)

Time frame: Day 1. Median (Full Range). Unit: Units on a Scale

Measure	Part 2 - Treatment A n = 8	Part 2 - Treatment B n = 8
Value	3 (1 to 4)	1.5 (1 to 4)

Population analysed: The populations for this taste assessment were Part 2 - Treatment A and Part 2 - Treatment B.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through end of study (up to approximately 6 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 - Treatment A	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
Part 1 - Treatment B	0 of 15 (0%)	9 of 15 (60%)	0 of 15
Part 1 - Treatment C	0 of 14 (0%)	8 of 15 (53.3%)	0 of 15
Part 1 - Treatment D	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14
Part 2 - Treatment A	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Part 2 - Treatment B	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 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?

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 4 inclusion and 8 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 28 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 United States. 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 28 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 Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) (time frame: Day 1 to Day 5). The study lists 3 primary outcomes in all. 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 NCT03847987.

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 28 May 2020.