Trial Outcomes & Findings for A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults (NCT NCT03758612)
NCT ID: NCT03758612
Last Updated: 2024-12-09
Results Overview
A treatment-related adverse event (AE) is defined for this study as any AE classified as possibly, probably or certainly related to the study drug. Adverse events (AEs) for participants who received at least one dose of study treatment were collected from the signing of informed consent till the end of study visit. An Investigator reviewed each AE collected and assessed its relationship to drug treatment based on all available information at the time of the completion of the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
Day 1 - Day 11
Results posted on
2024-12-09
Participant Flow
Cohort 3b, period 2, was added in protocol version 3.0. Some participants chose to return for period 2 and new participants were enrolled for period 2 of cohort 3b.
Participant milestones
| Measure |
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg oral suspension dosed under fasted conditions.
|
TBI-223 50 mg
Cohort 1, single dose of TBI-223 50 mg oral suspension dosed under fasted conditions.
|
TBI-223 100 mg
Cohort 2, single dose of TBI-223 100 mg oral suspension dosed under fasted conditions.
|
TBI-223 300 mg
Cohort 3a, Period 1 - gave a single dose of TBI-223 300 mg oral suspension dosed under fasted conditions.
Cohort 3b, Period 2 - participants in cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
|
TBI-223 1200 mg
Cohort 5, Period 1, single dose of TBI-223 1200 mg oral suspension dosed under fasted conditions.
Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg oral suspension dosed under fed conditions.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg oral suspension dosed under fasted conditions.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg oral suspension dosed under fasted conditions.
|
TBI-223 Placebo
Period 1 Single dose matching placebo for TBI-223 oral suspension under fasted conditions for cohorts 1 to 7
Period 2 Placebo participants in cohort 5 were invited to return after a washout period and were administered a single dose matching placebo for TBI-223 1200mg oral suspension under fed conditions
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions.
|
TBI-223 2x1000 mg IR Tablet
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
Cohort 9 Participants from Cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
8
|
6
|
8
|
14
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
6
|
8
|
14
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
0
|
0
|
0
|
6
|
8
|
0
|
0
|
2
|
0
|
0
|
0
|
6
|
|
Washout Period
COMPLETED
|
0
|
0
|
0
|
4
|
8
|
0
|
0
|
2
|
0
|
0
|
0
|
6
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
6
|
8
|
0
|
0
|
2
|
0
|
0
|
0
|
6
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
6
|
7
|
0
|
0
|
2
|
0
|
0
|
0
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg oral suspension dosed under fasted conditions.
|
TBI-223 50 mg
Cohort 1, single dose of TBI-223 50 mg oral suspension dosed under fasted conditions.
|
TBI-223 100 mg
Cohort 2, single dose of TBI-223 100 mg oral suspension dosed under fasted conditions.
|
TBI-223 300 mg
Cohort 3a, Period 1 - gave a single dose of TBI-223 300 mg oral suspension dosed under fasted conditions.
Cohort 3b, Period 2 - participants in cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
|
TBI-223 1200 mg
Cohort 5, Period 1, single dose of TBI-223 1200 mg oral suspension dosed under fasted conditions.
Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg oral suspension dosed under fed conditions.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg oral suspension dosed under fasted conditions.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg oral suspension dosed under fasted conditions.
|
TBI-223 Placebo
Period 1 Single dose matching placebo for TBI-223 oral suspension under fasted conditions for cohorts 1 to 7
Period 2 Placebo participants in cohort 5 were invited to return after a washout period and were administered a single dose matching placebo for TBI-223 1200mg oral suspension under fed conditions
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions.
|
TBI-223 2x1000 mg IR Tablet
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
Cohort 9 Participants from Cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Washout Period
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults
Baseline characteristics by cohort
| Measure |
TBI-223 Placebo
n=14 Participants
Part 1 Single dose matching placebo for TBI-223 under fasted conditions
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg
n=8 Participants
Cohort 3a, Period 1 - single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
Cohort 3b, Period 2 - participants in Cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
|
TBI-223 600 mg
n=6 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg
n=8 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg oral suspension dosed under fed conditions.
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=8 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 -Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet
n=6 Participants
Cohort 8, arm 4 -Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
Cohort 9 - Participants from Cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 3.93 • n=5 Participants
|
30 years
STANDARD_DEVIATION 7.45 • n=4 Participants
|
37.2 years
STANDARD_DEVIATION 9.11 • n=21 Participants
|
32.6 years
STANDARD_DEVIATION 8.81 • n=10 Participants
|
38.7 years
STANDARD_DEVIATION 8.48 • n=115 Participants
|
32.8 years
STANDARD_DEVIATION 7.81 • n=6 Participants
|
39.2 years
STANDARD_DEVIATION 8.30 • n=6 Participants
|
30.7 years
STANDARD_DEVIATION 4.89 • n=64 Participants
|
34.2 years
STANDARD_DEVIATION 9.13 • n=17 Participants
|
33.3 years
STANDARD_DEVIATION 8.31 • n=21 Participants
|
34.1 years
STANDARD_DEVIATION 8.42 • n=22 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
42 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
44 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
43 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
43 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
29 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
5 Participants
n=21 Participants
|
54 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
8 participants
n=10 Participants
|
6 participants
n=115 Participants
|
8 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=64 Participants
|
6 participants
n=17 Participants
|
6 participants
n=21 Participants
|
86 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 11Population: All participants who received at least one dose of study treatment. Note: participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
A treatment-related adverse event (AE) is defined for this study as any AE classified as possibly, probably or certainly related to the study drug. Adverse events (AEs) for participants who received at least one dose of study treatment were collected from the signing of informed consent till the end of study visit. An Investigator reviewed each AE collected and assessed its relationship to drug treatment based on all available information at the time of the completion of the study.
Outcome measures
| Measure |
TBI-223 Placebo
n=14 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=6 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=8 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=7 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=8 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
n=6 Participants
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. AUCs for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose.
AUC0-inf will be calculated from plasma concentrations of TBI-223 AND M2 and calculated as AUC0-inf = AUC0-t + Clast/λz, where λz is the apparent terminal elimination rate constant calculated by linear regression of the terminal linear portion of the log concentration versus time curve
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=8 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=7 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=6 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=6 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time- Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf)
TBI-223
|
1640 h*ng/mL
Standard Deviation 344
|
2730 h*ng/mL
Standard Deviation 628
|
10700 h*ng/mL
Standard Deviation 2100
|
8690 h*ng/mL
Standard Deviation 1690
|
25500 h*ng/mL
Standard Deviation 9580
|
45000 h*ng/mL
Standard Deviation 13800
|
47700 h*ng/mL
Standard Deviation 14300
|
107000 h*ng/mL
Standard Deviation 17800
|
127000 h*ng/mL
Standard Deviation 37800
|
71300 h*ng/mL
Standard Deviation 18800
|
69500 h*ng/mL
Standard Deviation 16000
|
82600 h*ng/mL
Standard Deviation 19400
|
86400 h*ng/mL
Standard Deviation 21200
|
100000 h*ng/mL
Standard Deviation 27300
|
—
|
|
Area Under the Plasma Concentration-time- Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf)
M2
|
663 h*ng/mL
Standard Deviation 106
|
1080 h*ng/mL
Standard Deviation 178
|
4640 h*ng/mL
Standard Deviation 881
|
4020 h*ng/mL
Standard Deviation 511
|
8889 h*ng/mL
Standard Deviation 2020
|
15900 h*ng/mL
Standard Deviation 2660
|
15800 h*ng/mL
Standard Deviation 2580
|
32900 h*ng/mL
Standard Deviation 7340
|
36700 h*ng/mL
Standard Deviation 4800
|
22700 h*ng/mL
Standard Deviation 5350
|
22700 h*ng/mL
Standard Deviation 4770
|
28400 h*ng/mL
Standard Deviation 7240
|
25100 h*ng/mL
Standard Deviation 3790
|
26000 h*ng/mL
Standard Deviation 3540
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. AUCs for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose. Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study.
AUC0-t will be calculated from plasma concentrations of TBI-223. Area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration (Clast), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=8 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=7 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=6 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=6 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-t
TBI-223
|
1620 h*ng/mL
Standard Deviation 343
|
2730 h*ng/mL
Standard Deviation 631
|
10700 h*ng/mL
Standard Deviation 2090
|
8640 h*ng/mL
Standard Deviation 1690
|
25500 h*ng/mL
Standard Deviation 9560
|
45900 h*ng/mL
Standard Deviation 13000
|
47600 h*ng/mL
Standard Deviation 14300
|
107000 h*ng/mL
Standard Deviation 17800
|
127000 h*ng/mL
Standard Deviation 37700
|
71000 h*ng/mL
Standard Deviation 18900
|
69400 h*ng/mL
Standard Deviation 16000
|
82600 h*ng/mL
Standard Deviation 19400
|
86300 h*ng/mL
Standard Deviation 21200
|
100000 h*ng/mL
Standard Deviation 27300
|
—
|
|
AUC0-t
M2
|
633 h*ng/mL
Standard Deviation 108
|
1050 h*ng/mL
Standard Deviation 177
|
4610 h*ng/mL
Standard Deviation 885
|
3980 h*ng/mL
Standard Deviation 516
|
8850 h*ng/mL
Standard Deviation 2020
|
16400 h*ng/mL
Standard Deviation 2840
|
15800 h*ng/mL
Standard Deviation 2590
|
32800 h*ng/mL
Standard Deviation 7340
|
36600 h*ng/mL
Standard Deviation 4790
|
22500 h*ng/mL
Standard Deviation 5420
|
22600 h*ng/mL
Standard Deviation 4770
|
28300 h*ng/mL
Standard Deviation 7230
|
25100 h*ng/mL
Standard Deviation 3800
|
26000 h*ng/mL
Standard Deviation 3530
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. Cmax for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose.
Cmax will be calculated from plasma concentrations of TBI-223. Cmax is calculated as the maximum plasma concentration, determined directly from individual concentration-time- data
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=8 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=7 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=6 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=6 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration, Determined Directly From Individual Concentration-time- Data (Cmax)
M2
|
109 ng/mL
Standard Deviation 15.7
|
196 ng/mL
Standard Deviation 31.3
|
897 ng/mL
Standard Deviation 195
|
489 ng/mL
Standard Deviation 137
|
1410 ng/mL
Standard Deviation 397
|
2240 ng/mL
Standard Deviation 345
|
2210 ng/mL
Standard Deviation 399
|
3550 ng/mL
Standard Deviation 871
|
3650 ng/mL
Standard Deviation 772
|
1830 ng/mL
Standard Deviation 557
|
2430 ng/mL
Standard Deviation 657
|
2480 ng/mL
Standard Deviation 499
|
2770 ng/mL
Standard Deviation 499
|
3620 ng/mL
Standard Deviation 847
|
—
|
|
Maximum Plasma Concentration, Determined Directly From Individual Concentration-time- Data (Cmax)
TBI-223
|
506 ng/mL
Standard Deviation 156
|
811 ng/mL
Standard Deviation 201
|
3090 ng/mL
Standard Deviation 664
|
1360 ng/mL
Standard Deviation 610
|
5800 ng/mL
Standard Deviation 2400
|
8530 ng/mL
Standard Deviation 1030
|
9150 ng/mL
Standard Deviation 2740
|
14800 ng/mL
Standard Deviation 2650
|
16200 ng/mL
Standard Deviation 4640
|
7040 ng/mL
Standard Deviation 2010
|
9580 ng/mL
Standard Deviation 3390
|
8490 ng/mL
Standard Deviation 1670
|
12800 ng/mL
Standard Deviation 2320
|
19700 ng/mL
Standard Deviation 5640
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures.
Tmax will be calculated from plasma concentrations of TBI-223.
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=8 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=7 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=6 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=6 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of the Maximum Plasma Concentrations (Tmax)
TBI-223
|
1.0 hours
Interval 0.5 to 1.0
|
1.50 hours
Interval 1.0 to 2.0
|
1.37 hours
Interval 1.0 to 1.53
|
5.00 hours
Interval 3.0 to 16.0
|
1.75 hours
Interval 1.0 to 4.0
|
1.50 hours
Interval 1.0 to 3.02
|
1.50 hours
Interval 0.5 to 3.0
|
1.52 hours
Interval 1.0 to 3.05
|
2.25 hours
Interval 1.5 to 5.0
|
7.00 hours
Interval 6.0 to 16.0
|
6.50 hours
Interval 4.0 to 8.0
|
7.50 hours
Interval 5.0 to 20.0
|
2.00 hours
Interval 1.0 to 3.0
|
3.00 hours
Interval 1.0 to 4.0
|
—
|
|
Time of the Maximum Plasma Concentrations (Tmax)
M2
|
1.00 hours
Interval 0.5 to 3.0
|
1.50 hours
Interval 1.0 to 3.0
|
1.50 hours
Interval 1.5 to 3.0
|
5.50 hours
Interval 3.0 to 16.0
|
2.50 hours
Interval 1.0 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.50 hours
Interval 3.0 to 4.03
|
4.00 hours
Interval 3.0 to 5.0
|
7.50 hours
Interval 7.0 to 16.0
|
7.50 hours
Interval 4.0 to 8.0
|
8.00 hours
Interval 5.0 to 20.0
|
3.00 hours
Interval 3.0 to 4.0
|
3.00 hours
Interval 1.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures.
T1/2 will be calculated from plasma concentrations of TBI-223 and calculated as T½ = ln(2)/λz
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 Participants
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 Participants
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=8 Participants
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=7 Participants
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=6 Participants
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 Participants
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=6 Participants
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 Participants
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 Participants
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 Participants
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 Participants
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Observed Terminal Elimination Half-life (t1/2)
TBI-223
|
2.19 hours
Standard Deviation 0.239
|
1.96 hours
Standard Deviation 0.165
|
1.94 hours
Standard Deviation 0.238
|
3.43 hours
Standard Deviation 1.02
|
2.63 hours
Standard Deviation 0.693
|
2.93 hours
Standard Deviation 0.706
|
2.32 hours
Standard Deviation 0.158
|
3.81 hours
Standard Deviation 0.870
|
2.93 hours
Standard Deviation 0.534
|
3.70 hours
Standard Deviation 0.271
|
2.32 hours
Standard Deviation 0.581
|
3.08 hours
Standard Deviation 0.784
|
2.80 hours
Standard Deviation 0.604
|
2.38 hours
Standard Deviation 0.101
|
—
|
|
The Observed Terminal Elimination Half-life (t1/2)
M2
|
2.62 hours
Standard Deviation 0.256
|
2.41 hours
Standard Deviation 0.238
|
2.25 hours
Standard Deviation 0.403
|
3.93 hours
Standard Deviation 1.36
|
3.17 hours
Standard Deviation 0.585
|
3.33 hours
Standard Deviation 0.635
|
2.72 hours
Standard Deviation 0.207
|
4.44 hours
Standard Deviation 0.698
|
3.74 hours
Standard Deviation 0.752
|
4.21 hours
Standard Deviation 2.45
|
2.77 hours
Standard Deviation 0.728
|
3.61 hours
Standard Deviation 0.843
|
3.24 hours
Standard Deviation 0.604
|
2.97 hours
Standard Deviation 0.325
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: Participants enrolled in cohort 3a and cohort 3b who received TBI-223. Participants from cohort 3a were invited to participate in cohort 3b and additional participants were enrolled in 3b to replace those who elected not to participate.
Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 300 mg Dose of TBI-223 Capsule Formulation (Cohort 3 Repeat; Part 1; Test) and a Single 300 mg Dose of TBI-223 Oral Suspension (Cohort 3; Part 1; Reference).
Outcome measures
| Measure |
TBI-223 Placebo
n=8 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 300 mg TBI-223 in Capsule to Oral Suspension Formulations
Cmax
|
42.46 ratio (%)
Interval 31.57 to 57.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 300 mg TBI-223 in Capsule to Oral Suspension Formulations
AUC0-t
|
94.43 ratio (%)
Interval 90.28 to 98.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 300 mg TBI-223 in Capsule to Oral Suspension Formulations
AUC0-inf
|
94.73 ratio (%)
Interval 90.58 to 99.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: All participants who enrolled in cohort 5 and received TBI-223. Participants in period 1 were invited to participate in period 2.
Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 1200 mg Dose of TBI-223 Oral Suspension under Fed (Test) and Fasted (Reference) Conditions (Part 1; Cohort 5)
Outcome measures
| Measure |
TBI-223 Placebo
n=8 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1200 mg Oral Suspension Under Fasted to Fed Conditions
Cmax
|
103.34 ratio (%)
Interval 87.0 to 122.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1200 mg Oral Suspension Under Fasted to Fed Conditions
AUC0-t
|
103.23 ratio (%)
Interval 97.8 to 108.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1200 mg Oral Suspension Under Fasted to Fed Conditions
AUC0-inf
|
102.79 ratio (%)
Interval 96.37 to 109.64
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: All participants who enrolled were enrolled in cohort 8, arm 4 and were also enrolled in cohort 9.
Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as IR tablets, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 9; Test) and IR tablets, 2000 mg (2 x1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference)
Outcome measures
| Measure |
TBI-223 Placebo
n=6 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 2000 mg of Immediate Release (IR) Tablets Under Fed to Fasted Conditions.
AUC0-t
|
115.73 ratio (%)
Interval 112.08 to 119.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 2000 mg of Immediate Release (IR) Tablets Under Fed to Fasted Conditions.
Cmax
|
151.24 ratio (%)
Interval 127.91 to 178.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 2000 mg of Immediate Release (IR) Tablets Under Fed to Fasted Conditions.
ACU0-inf
|
115.70 ratio (%)
Interval 112.06 to 119.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: SR-1, SR-2, and SR-3 parameters were dose-normalized to 2000 mg prior to analysis
Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as SR (Prototypes 1, 2, and 3) under Fed Conditions (Cohort 8; Test) and IR, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference)
Outcome measures
| Measure |
TBI-223 Placebo
n=12 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=12 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=12 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of TBI-223 1800 mg Sustained Release (SR) Tablets Under Fed Conditions to 2000 mg IR Tablets Under Fasted Conditions
AUC0-t
|
81.11 ratio (%)
Interval 62.92 to 104.56
|
80.55 ratio (%)
Interval 62.49 to 103.84
|
95.71 ratio (%)
Interval 74.25 to 123.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of TBI-223 1800 mg Sustained Release (SR) Tablets Under Fed Conditions to 2000 mg IR Tablets Under Fasted Conditions
AUC 0-inf
|
81.52 ratio (%)
Interval 63.26 to 105.04
|
80.56 ratio (%)
Interval 62.51 to 103.81
|
95.73 ratio (%)
Interval 74.29 to 123.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of TBI-223 1800 mg Sustained Release (SR) Tablets Under Fed Conditions to 2000 mg IR Tablets Under Fasted Conditions
Cmax
|
53.53 ratio (%)
Interval 40.1 to 71.45
|
71.70 ratio (%)
Interval 53.71 to 95.71
|
66.31 ratio (%)
Interval 49.67 to 88.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational productPopulation: SR-1, SR-2, and SR-3 parameters were dose-normalized to 2000 mg prior to analysis
Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as TBI-223 after 1800 mg SR tablets (Prototypes 1, 2, 3,) under Fed Conditions (Cohort 8; Test) and 2000 mg IR tablets (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 8; Reference)
Outcome measures
| Measure |
TBI-223 Placebo
n=12 Participants
Part 1 Single dose matching placebo for TBI-223 cohorts 1 to 7
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=12 Participants
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=12 Participants
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1800 mg SR Tablets (Prototypes 1, 2, 3,) to 2000 mg IR Tablets Under Fed Conditions
AUC0-t
|
70.09 ratio (%)
Interval 54.1 to 90.81
|
69.60 ratio (%)
Interval 53.72 to 90.18
|
82.70 ratio (%)
Interval 63.83 to 107.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1800 mg SR Tablets (Prototypes 1, 2, 3,) to 2000 mg IR Tablets Under Fed Conditions
Cmax
|
35.39 ratio (%)
Interval 26.04 to 48.1
|
47.41 ratio (%)
Interval 34.88 to 64.43
|
43.85 ratio (%)
Interval 32.26 to 59.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1800 mg SR Tablets (Prototypes 1, 2, 3,) to 2000 mg IR Tablets Under Fed Conditions
AUC0-inf
|
70.45 ratio (%)
Interval 54.4 to 91.24
|
69.62 ratio (%)
Interval 53.76 to 90.17
|
82.74 ratio (%)
Interval 63.88 to 107.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
TBI-223 Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TBI-223 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TBI-223 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TBI-223 300 mg Oral Suspension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TBI-223 300 mg Oral Enteric Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TBI-223 600 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TBI-223 1200 mg Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TBI-223 1200 mg Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TBI-223 2000 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TBI-223 2600 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TBI-223 3x600 mg SR-1 Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TBI-223 3x600 mg SR-2 Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TBI-223 2x900 mg SR-3 Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TBI-223 2x1000 mg IR Tablet Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TBI-223 2x1000 mg IR Tablet Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TBI-223 Placebo
n=14 participants at risk
Part 1 Single dose matching placebo for TBI-223
Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered.
|
TBI-223 50 mg
n=6 participants at risk
Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 100 mg
n=6 participants at risk
Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Suspension
n=6 participants at risk
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 300 mg Oral Enteric Capsules
n=6 participants at risk
Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions
TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.
|
TBI-223 600 mg
n=6 participants at risk
Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fasted
n=8 participants at risk
Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 1200 mg Fed
n=7 participants at risk
Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2000 mg
n=6 participants at risk
Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 2600 mg
n=8 participants at risk
Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions
TBI-223 oral suspension: TBI-223 oral suspension, orally administered.
|
TBI-223 3x600 mg SR-1 Tablet
n=6 participants at risk
Cohort 8, arm 1 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions
TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.
|
TBI-223 3x600 mg SR-2 Tablet
n=6 participants at risk
Cohort 8, arm 2 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions
TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered.
|
TBI-223 2x900 mg SR-3 Tablet
n=6 participants at risk
Cohort 8, arm 3 -Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions
TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered.
|
TBI-223 2x1000 mg IR Tablet Fasted
n=6 participants at risk
Cohort 8, arm 4 -Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
TBI-223 2x1000 mg IR Tablet Fed
n=6 participants at risk
Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions
TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
33.3%
2/6 • Number of events 2 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
37.5%
3/8 • Number of events 5 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
25.0%
2/8 • Number of events 2 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
14.3%
1/7 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
25.0%
2/8 • Number of events 2 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
33.3%
2/6 • Number of events 2 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
12.5%
1/8 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
12.5%
1/8 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Energy Increased
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Medical device site reaction
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
7.1%
1/14 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Vessel puncture site inflammation
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
33.3%
2/6 • Number of events 2 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/14 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/7 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/8 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
0.00%
0/6 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
16.7%
1/6 • Number of events 1 • Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place