Healthy Volunteers
Conditions
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.
Interventions
DRUGRO7017773 Phase I Capsule
Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.
DRUGRO7017773 Phase II Tablet Unflavored
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.
DRUGRO7017773 Phase II Tablet Sweetened/Flavored
Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Taste Assessment, as Measured by Taste Questionnaire (Part 1) | 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. |
| Percentage of Participants With Adverse Events (AEs) | Baseline through end of study (approximately 6 weeks) | — |
Countries
United States
Participant flow
Recruitment details
Healthy male and female participants between ages 18-55 years, who were nonsmokers for at least 6 months.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Part 2 | Total | Part 1 |
|---|---|---|---|
| Age, Continuous | 35.3 Years STANDARD_DEVIATION 10.57 | 33.7 Years STANDARD_DEVIATION 4.44 | 32.1 Years STANDARD_DEVIATION 9.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 18 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 15 | 0 / 14 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 9 / 16 | 9 / 15 | 8 / 15 | 4 / 14 | 6 / 8 | 5 / 8 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Cmax of RO7017773 (Part 2)
Time frame: Day 1 to Day 5
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - Treatment A | Cmax of RO7017773 (Part 2) | 1470 ng/mL | Geometric Coefficient of Variation 25.2 |
| Part 1 - Treatment B | Cmax of RO7017773 (Part 2) | 1210 ng/mL | Geometric Coefficient of Variation 19 |
Primary
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Time frame: Day 1 to Day 5
Population: The PK population included all participants.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 - Treatment A | Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) | 1320 ng/mL | Geometric Coefficient of Variation 25.8 |
| Part 1 - Treatment B | Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) | 1570 ng/mL | Geometric Coefficient of Variation 27.4 |
| Part 1 - Treatment C | Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) | 1120 ng/mL | Geometric Coefficient of Variation 25.3 |
| Part 1 - Treatment D | Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) | 1490 ng/mL | Geometric Coefficient of Variation 26.6 |
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.
Time frame: Day 1
Population: The populations for this taste assessment were Part 2 - Treatment A and Part 2 - Treatment B.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 - Treatment A | Taste Assessment, as Measured by Taste Questionnaire (Part 2) | 3 Units on a Scale |
| Part 1 - Treatment B | Taste Assessment, as Measured by Taste Questionnaire (Part 2) | 1.5 Units on a Scale |
Secondary
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline through end of study (approximately 6 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 - Treatment A | Percentage of Participants With Adverse Events (AEs) | 56.3 Percentage of Participants |
| Part 1 - Treatment B | Percentage of Participants With Adverse Events (AEs) | 60.0 Percentage of Participants |
| Part 1 - Treatment C | Percentage of Participants With Adverse Events (AEs) | 53.3 Percentage of Participants |
| Part 1 - Treatment D | Percentage of Participants With Adverse Events (AEs) | 28.6 Percentage of Participants |
| Part 2 - Treatment A | Percentage of Participants With Adverse Events (AEs) | 75.0 Percentage of Participants |
| Part 2 - Treatment B | Percentage of Participants With Adverse Events (AEs) | 62.5 Percentage of Participants |
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.
Time frame: Day 1
Population: The population for this taste assessment was Part 1 - Treatment D (study drug dispersed in water).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 - Treatment A | Taste Assessment, as Measured by Taste Questionnaire (Part 1) | 2 Units on a Scale |