Trial Outcomes & Findings for INDV-2000 First in Human (NCT NCT04413552)
NCT ID: NCT04413552
Last Updated: 2024-05-16
Results Overview
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Results posted on
2024-05-16
Participant Flow
Healthy volunteers were enrolled at a single site in Overland Park, Kansas, United States.
This study was conducted in 2 parts: Part I was a double-blind, placebo-controlled, randomized, single ascending dose (SAD) study in which participants were randomized in cohorts of 8 subjects with 6 subjects receiving active drug and 2 subjects receiving placebo. Part II was an open-label, cross-over, food interaction, single-dose study with INDV-2000 administered once under fasting conditions and once after completion of a standard high-fat breakfast.
Participant milestones
| Measure |
Part I: INDV-2000 1 mg
Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II: INDV-2000 360 mg Fasted/Fed
Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
16
|
8
|
|
Overall Study
Received Study Drug
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part I: INDV-2000 1 mg
Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II: INDV-2000 360 mg Fasted/Fed
Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Demographic data are reported separately for Part I and Part II.
Baseline characteristics by cohort
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 Participants
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II: INDV-2000 360 mg Fasted/Fed
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part I
|
42.0 years
STANDARD_DEVIATION 12.05 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
42.2 years
STANDARD_DEVIATION 12.80 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
34.3 years
STANDARD_DEVIATION 4.41 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
40.5 years
STANDARD_DEVIATION 10.93 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
33.5 years
STANDARD_DEVIATION 11.20 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
31.5 years
STANDARD_DEVIATION 12.36 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
44.3 years
STANDARD_DEVIATION 6.74 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
31.8 years
STANDARD_DEVIATION 11.34 • n=6 Participants • Demographic data are reported separately for Part I and Part II.
|
36.5 years
STANDARD_DEVIATION 11.49 • n=16 Participants • Demographic data are reported separately for Part I and Part II.
|
—
|
37.3 years
STANDARD_DEVIATION 11.02 • n=64 Participants • Demographic data are reported separately for Part I and Part II.
|
|
Age, Continuous
Part II
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40.4 years
STANDARD_DEVIATION 7.52 • n=8 Participants • Demographic data are reported separately for Part I and Part II.
|
40.4 years
STANDARD_DEVIATION 7.52 • n=8 Participants • Demographic data are reported separately for Part I and Part II.
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
13 Participants
n=16 Participants
|
8 Participants
n=8 Participants
|
58 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
15 Participants
n=16 Participants
|
8 Participants
n=8 Participants
|
66 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=16 Participants
|
4 Participants
n=8 Participants
|
32 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=16 Participants
|
4 Participants
n=8 Participants
|
36 Participants
n=72 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).Population: Participants who received at least one dose of study drug (safety population)
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 Participants
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Drug-related TEAE
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment-emergent adverse event (TEAE)
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent serious adverse events (TESAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Drug-related TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE with grade 3 or higher toxicity
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Fatal TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).Population: Participants who received at least one dose of study drug (safety population)
The investigator assessed abnormal laboratory values to determine clinical significance.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 Participants
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Findings
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).Population: Participants who received at least one dose of study drug (safety population)
The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 Participants
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).Population: Participants who received at least one dose of study drug (safety population)
The investigator assessed abnormal ECG values to determine clinical significance.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 Participants
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
n=8 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).Population: Clinically significant physical examination findings were not recorded separately.
Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters (PK population).
Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose
|
16.7 ng/mL
Standard Deviation 3.93
|
87.6 ng/mL
Standard Deviation 26.4
|
194 ng/mL
Standard Deviation 33.3
|
489 ng/mL
Standard Deviation 147
|
1000 ng/mL
Standard Deviation 343
|
1100 ng/mL
Standard Deviation 238
|
1880 ng/mL
Standard Deviation 1140
|
2080 ng/mL
Standard Deviation 688
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose
|
1.00 hours
Interval 0.58 to 2.08
|
0.50 hours
Interval 0.5 to 1.15
|
2.50 hours
Interval 1.0 to 3.05
|
2.02 hours
Interval 1.0 to 3.0
|
2.00 hours
Interval 1.0 to 2.0
|
3.50 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 2.0 to 3.0
|
3.00 hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose
|
67.3 ng*h/mL
Standard Deviation 17.7
|
312 ng*h/mL
Standard Deviation 181
|
915 ng*h/mL
Standard Deviation 186
|
2340 ng*h/mL
Standard Deviation 1020
|
6900 ng*h/mL
Standard Deviation 4050
|
8520 ng*h/mL
Standard Deviation 1600
|
17800 ng*h/mL
Standard Deviation 9800
|
28700 ng*h/mL
Standard Deviation 7810
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=5 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose
|
69.5 ng*h/mL
Standard Deviation 19.1
|
317 ng*h/mL
Standard Deviation 180
|
907 ng*h/mL
Standard Deviation 207
|
2350 ng*h/mL
Standard Deviation 1030
|
6920 ng*h/mL
Standard Deviation 4060
|
8530 ng*h/mL
Standard Deviation 1590
|
17800 ng*h/mL
Standard Deviation 9810
|
28700 ng*h/mL
Standard Deviation 7810
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=5 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose
|
15.4 L/h
Standard Deviation 4.31
|
18.8 L/h
Standard Deviation 6.98
|
23.2 L/h
Standard Deviation 6.70
|
24.5 L/h
Standard Deviation 9.67
|
22.4 L/h
Standard Deviation 11.7
|
21.7 L/h
Standard Deviation 4.03
|
25.8 L/h
Standard Deviation 13.4
|
26.7 L/h
Standard Deviation 7.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=5 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose
|
2.19 hours
Standard Deviation 0.32
|
2.52 hours
Standard Deviation 0.46
|
2.56 hours
Standard Deviation 0.37
|
2.81 hours
Standard Deviation 0.47
|
3.56 hours
Standard Deviation 1.18
|
3.47 hours
Standard Deviation 0.46
|
4.57 hours
Standard Deviation 0.58
|
5.28 hours
Standard Deviation 2.18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000
|
12.2 ng/mL
Standard Deviation 3.31
|
76.4 ng/mL
Standard Deviation 14.4
|
182 ng/mL
Standard Deviation 34.0
|
372 ng/mL
Standard Deviation 113
|
983 ng/mL
Standard Deviation 121
|
963 ng/mL
Standard Deviation 326
|
1650 ng/mL
Standard Deviation 536
|
1840 ng/mL
Standard Deviation 318
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000
|
1.08 hours
Interval 1.0 to 2.08
|
0.50 hours
Interval 0.5 to 1.15
|
3.50 hours
Interval 1.0 to 4.0
|
2.52 hours
Interval 1.0 to 4.0
|
3.00 hours
Interval 3.0 to 4.0
|
4.00 hours
Interval 4.0 to 6.0
|
3.00 hours
Interval 2.0 to 8.0
|
3.00 hours
Interval 3.0 to 8.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000
|
72.8 ng*h/mL
Standard Deviation 28.8
|
413 ng*h/mL
Standard Deviation 223
|
1300 ng*h/mL
Standard Deviation 489
|
3190 ng*h/mL
Standard Deviation 2250
|
10000 ng*h/mL
Standard Deviation 4370
|
10100 ng*h/mL
Standard Deviation 5540
|
24000 ng*h/mL
Standard Deviation 16200
|
25800 ng*h/mL
Standard Deviation 6120
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000
|
74.8 ng*h/mL
Standard Deviation 30.3
|
417 ng*h/mL
Standard Deviation 222
|
1310 ng*h/mL
Standard Deviation 489
|
3200 ng*h/mL
Standard Deviation 2240
|
10100 ng*h/mL
Standard Deviation 4370
|
10100 ng*h/mL
Standard Deviation 5540
|
24000 ng*h/mL
Standard Deviation 16200
|
25800 ng*h/mL
Standard Deviation 6110
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 Participants
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 Participants
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 Participants
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 Participants
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 Participants
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 Participants
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000
|
3.78 hours
Standard Deviation 0.84
|
4.04 hours
Standard Deviation 0.73
|
3.93 hours
Standard Deviation 0.50
|
4.23 hours
Standard Deviation 1.21
|
4.51 hours
Standard Deviation 0.81
|
4.45 hours
Standard Deviation 0.56
|
5.54 hours
Standard Deviation 1.07
|
5.87 hours
Standard Deviation 2.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
1700 ng/mL
Standard Deviation 584
|
2720 ng/mL
Standard Deviation 796
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
3.00 hours
Interval 2.0 to 6.0
|
3.00 hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
18200 ng*hr/mL
Standard Deviation 6060
|
16700 ng*hr/mL
Standard Deviation 7970
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
19700 ng*hr/mL
Standard Deviation 7690
|
17400 ng*hr/mL
Standard Deviation 8130
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
21.2 L/hr
Standard Deviation 9.61
|
24.1 L/hr
Standard Deviation 9.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=6 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
|
6.37 hours
Standard Deviation 1.62
|
2.91 hours
Standard Deviation 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
|
1320 ng/mL
Standard Deviation 243
|
1500 ng/mL
Standard Deviation 277
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
|
4.00 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=8 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
|
15800 ng*hr/mL
Standard Deviation 4180
|
15000 ng*hr/mL
Standard Deviation 3920
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=7 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
|
18200 ng*hr/mL
Standard Deviation 4030
|
15800 ng*hr/mL
Standard Deviation 4300
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dosePopulation: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
Outcome measures
| Measure |
Part I: INDV-2000 1 mg
n=7 Participants
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=8 Participants
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
|
7.43 hours
Standard Deviation 1.13
|
5.21 hours
Standard Deviation 1.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part I: INDV-2000 1 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part I: INDV-2000 5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: INDV-2000 20 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part I: INDV-2000 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part I: INDV-2000 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: INDV-2000 180 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part I: INDV-2000 360 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part I: INDV-2000 720 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part I: Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part II Period 1: INDV-2000 360 mg Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part II Period 2: INDV-2000 360 mg Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part I: INDV-2000 1 mg
n=6 participants at risk
Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 5 mg
n=6 participants at risk
Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 20 mg
n=6 participants at risk
Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 50 mg
n=6 participants at risk
Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 120 mg
n=6 participants at risk
Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 180 mg
n=6 participants at risk
Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 360 mg
n=6 participants at risk
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: INDV-2000 720 mg
n=6 participants at risk
Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.
|
Part I: Pooled Placebo
n=16 participants at risk
Participants received a single dose of matching placebo orally under fasted conditions on Day 1.
|
Part II Period 1: INDV-2000 360 mg Fasted
n=8 participants at risk
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.
|
Part II Period 2: INDV-2000 360 mg Fed
n=8 participants at risk
Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
4/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
2/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
6.2%
1/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Body tinea
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/16 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will not disseminate, present or publish any of the study data without the prior written approval from Indivior to do so.
- Publication restrictions are in place
Restriction type: OTHER