A 2 Part Study to Assess the Relative Bioavailability of... | NCT03847987 | Trialant
NCT03847987
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
May 28, 2020Actual
Enrollment
24Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
RO7017773 Phase I Capsule
RO7017773 Phase II Tablet Unflavored
RO7017773 Phase II Tablet Sweetened/Flavored
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03847987
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP40950
Secondary IDs
Not provided
Brief Title
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
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
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 12, 2019Actual
Primary Completion Date
Apr 22, 2019Actual
Completion Date
Apr 22, 2019Actual
First Submitted Date
Feb 19, 2019
First Submission Date that Met QC Criteria
Feb 19, 2019
First Posted Date
Feb 20, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 8, 2020
Results First Submitted that Met QC Criteria
May 14, 2020
Results First Posted Date
May 28, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2020
Last Update Posted Date
May 28, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Volunteers
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
24Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
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.
Drug: RO7017773 Phase II Tablet Unflavored
Drug: RO7017773 Phase II Tablet Sweetened/Flavored
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7017773 Phase I Capsule
Drug
Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.
Part 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Day 1 to Day 5
Cmax of RO7017773 (Part 2)
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.
Day 1
Secondary Outcomes
Measure
Description
Time Frame
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.
Day 1
Percentage of Participants With Adverse Events (AEs)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
PRA Health Sciences
Salt Lake City
Utah
84124
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Healthy male and female participants between ages 18-55 years, who were nonsmokers for at least 6 months.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1
Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Treatment sequences were randomly assigned
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 28, 2019
Apr 8, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
RO7017773 Phase II Tablet Unflavored
Drug
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.
Part 1
Part 2
RO7017773 Phase II Tablet Sweetened/Flavored
Drug
Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
Part 2
Baseline through end of study (approximately 6 weeks)
FG001
Part 2
Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Treatment sequences were randomly assigned
FG00016 subjects
FG0018 subjects
COMPLETED
FG00013 subjects
FG0018 subjects
NOT COMPLETED
FG0003 subjects
FG0010 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
Adverse Event
FG0002 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1
Sixteen (16) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
Treatment A = A single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
Treatment B = A single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
Treatment C = A single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
Treatment D = A single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Treatment sequences were randomly assigned
BG001
Part 2
Eight (8) total participants received each of the following treatments, with a 7-10 day washout period between treatments:
Treatment A (taste assessment) = A single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
Treatment B (taste assessment) = A single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Treatment sequences were randomly assigned
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0018
BG00224
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00032.1± 9.66
BG00135.3± 10.57
BG00233.7± 4.44
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
The PK population included all participants.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 to Day 5
ID
Title
Description
OG000
Part 1 - Treatment A
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
OG001
Part 1 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
OG002
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
OG003
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Units
Counts
Participants
OG00016
OG00116
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG0001320± 25.8
OG0011570± 27.4
OG0021120± 25.3
OG003
Secondary
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.
The population for this taste assessment was Part 1 - Treatment D (study drug dispersed in water).
Posted
Median
Full Range
Units on a Scale
Day 1
ID
Title
Description
OG000
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
Units
Counts
Participants
OG000
Primary
Cmax of RO7017773 (Part 2)
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 to Day 5
ID
Title
Description
OG000
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
OG001
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Units
Counts
Participants
OG000
Primary
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.
The populations for this taste assessment were Part 2 - Treatment A and Part 2 - Treatment B.
Posted
Median
Full Range
Units on a Scale
Day 1
ID
Title
Description
OG000
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
OG001
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Adverse Events (AEs)
Posted
Number
Percentage of Participants
Baseline through end of study (approximately 6 weeks)
ID
Title
Description
OG000
Part 1 - Treatment A
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
OG001
Part 1 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
OG002
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
OG003
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
OG004
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
Time Frame
Baseline through end of study (up to approximately 6 weeks)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 - Treatment A
Participants received a single oral dose of RO7017773 (capsule) swallowed whole under fasted conditions
0
16
0
16
9
16
EG001
Part 1 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fasted conditions
0
15
0
15
9
15
EG002
Part 1 - Treatment C
Participants received a single oral dose of RO7017773 (tablet) swallowed whole under fed conditions
0
15
0
14
8
15
EG003
Part 1 - Treatment D
Participants received a single oral dose of RO7017773 (tablet) dispersed in water under fasted conditions
0
14
0
14
4
14
EG004
Part 2 - Treatment A
Participants received a single oral dose of RO7017773 (tablet) containing flavor/sweetener dispersed in water under fasted conditions
0
8
0
8
6
8
EG005
Part 2 - Treatment B
Participants received a single oral dose of RO7017773 (tablet) with no flavor/sweetener dispersed in apple juice under fasted conditions
0
8
0
8
5
8
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG0031 events1 affected14 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
Nausea
Gastrointestinal disorders
Non-systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected15 at risk
EG0022 events1 affected15 at risk
EG003
Flatulence
Gastrointestinal disorders
Non-systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Non-systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Pain
General disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Fatigue
General disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood pressure increased
Investigations
Non-systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatinine increased
Investigations
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatine phosphokinase increased
Investigations
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Somnolence
Nervous system disorders
Non-systematic Assessment
EG0002 events2 affected16 at risk
EG0012 events2 affected15 at risk
EG0023 events3 affected14 at risk
EG003
Headache
Nervous system disorders
Non-systematic Assessment
EG0005 events4 affected16 at risk
EG0014 events4 affected15 at risk
EG0022 events2 affected15 at risk
EG003
Dizziness
Nervous system disorders
Non-systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Sleep paralysis
Nervous system disorders
Non-systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected15 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.