Trial Outcomes & Findings for Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder (NCT NCT04976855)
NCT ID: NCT04976855
Last Updated: 2024-08-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II).
Results posted on
2024-08-21
Participant Flow
The study was conducted in 3 parts: Part I and Part II in healthy volunteers, and Part III in treatment seeking individuals with opioid use disorder (OUD).
Participant milestones
| Measure |
Part I: INDV-2000 100 mg QD
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
Part III: INDV-2000 400 mg BID + SUBOXONE SL
A single cohort of treatment seeking participants with opioid use disorder (OUD) received SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants then received SUBOXONE SL film alone on Days 1 and 2, then SUBOXONE SL film and INDV-2000 on Days 3-9, followed by INDV-2000 alone on Days 10-13.
INDV-2000: Two 200 mg/capsule for oral administration
SUBOXONE® sublingual film: Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
|
|---|---|---|---|---|---|---|---|
|
Part I
STARTED
|
9
|
9
|
6
|
0
|
0
|
0
|
0
|
|
Part I
COMPLETED
|
9
|
8
|
6
|
0
|
0
|
0
|
0
|
|
Part I
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part II
STARTED
|
0
|
0
|
0
|
9
|
9
|
6
|
0
|
|
Part II
COMPLETED
|
0
|
0
|
0
|
8
|
8
|
5
|
0
|
|
Part II
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Part III: Run-in Period (6 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
|
Part III: Run-in Period (6 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
|
Part III: Run-in Period (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part III: Treatment Period (14 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
|
Part III: Treatment Period (14 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
|
Part III: Treatment Period (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part I: INDV-2000 100 mg QD
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
Part III: INDV-2000 400 mg BID + SUBOXONE SL
A single cohort of treatment seeking participants with opioid use disorder (OUD) received SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants then received SUBOXONE SL film alone on Days 1 and 2, then SUBOXONE SL film and INDV-2000 on Days 3-9, followed by INDV-2000 alone on Days 10-13.
INDV-2000: Two 200 mg/capsule for oral administration
SUBOXONE® sublingual film: Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
|
|---|---|---|---|---|---|---|---|
|
Part I
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part II
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part II
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part II
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Part I: INDV-2000 100 mg QD
n=9 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=6 Participants
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
n=6 Participants
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
Part III: INDV-2000 400 mg BID + SUBOXONE SL
n=16 Participants
A single cohort of treatment seeking participants with opioid use disorder (OUD) received SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants then received SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days, followed by INDV-2000 dosing alone for 4 days.
INDV-2000: Two 200 mg/capsule for oral administration
SUBOXONE® sublingual film: Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 8.17 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 9.00 • n=21 Participants
|
35.7 years
STANDARD_DEVIATION 11.31 • n=10 Participants
|
39.9 years
STANDARD_DEVIATION 4.89 • n=115 Participants
|
39.1 years
STANDARD_DEVIATION 8.31 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
52 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
32 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
30 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
6 participants
n=10 Participants
|
16 participants
n=115 Participants
|
64 participants
n=24 Participants
|
|
Weight
|
78.18 kg
STANDARD_DEVIATION 10.103 • n=5 Participants
|
82.67 kg
STANDARD_DEVIATION 11.630 • n=7 Participants
|
86.20 kg
STANDARD_DEVIATION 15.129 • n=5 Participants
|
76.48 kg
STANDARD_DEVIATION 5.833 • n=4 Participants
|
82.00 kg
STANDARD_DEVIATION 16.252 • n=21 Participants
|
82.25 kg
STANDARD_DEVIATION 13.536 • n=10 Participants
|
86.24 kg
STANDARD_DEVIATION 19.333 • n=115 Participants
|
82.26 kg
STANDARD_DEVIATION 14.226 • n=24 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II).Outcome measures
| Measure |
Part I: INDV-2000 100 mg QD
n=9 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=6 Participants
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
n=6 Participants
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Part I and Part II: Number of Participants With Adverse Events
Any TEAE
|
5 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Serious
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Study drug-related
|
5 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Serious and Study drug-related
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part I and Part II: Number of Participants With Adverse Events
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of INDV-2000 up to 7 days after last dose (up to 18 days).Outcome measures
| Measure |
Part I: INDV-2000 100 mg QD
n=16 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Part III: Number of Participants With Adverse Events
Any TEAE
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Serious
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Study-drug related
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Serious and Study-drug related
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Discontinuation
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part III: Number of Participants With Adverse Events
Death
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: Pharmacokinetic Population
Day 28 is only for Part II.
Outcome measures
| Measure |
Part I: INDV-2000 100 mg QD
n=9 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=9 Participants
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 1
|
849 ng/mL
Geometric Coefficient of Variation 51.9
|
759 ng/mL
Geometric Coefficient of Variation 36.3
|
1480 ng/mL
Geometric Coefficient of Variation 50.1
|
1830 ng/mL
Geometric Coefficient of Variation 43.8
|
—
|
—
|
|
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 7
|
967 ng/mL
Geometric Coefficient of Variation 34.3
|
855 ng/mL
Geometric Coefficient of Variation 32.6
|
1570 ng/mL
Geometric Coefficient of Variation 49.0
|
1670 ng/mL
Geometric Coefficient of Variation 45.2
|
—
|
—
|
|
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 28
|
—
|
—
|
1780 ng/mL
Geometric Coefficient of Variation 40.0
|
1920 ng/mL
Geometric Coefficient of Variation 36.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: Pharmacokinetic Population
Day 28 is only for Part II
Outcome measures
| Measure |
Part I: INDV-2000 100 mg QD
n=9 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=9 Participants
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 1
|
4 hour
Interval 2.0 to 8.0
|
2 hour
Interval 2.0 to 8.0
|
3 hour
Interval 2.0 to 6.0
|
2 hour
Interval 2.0 to 4.0
|
—
|
—
|
|
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 7
|
3 hour
Interval 2.0 to 6.0
|
1 hour
Interval 1.0 to 4.0
|
4 hour
Interval 2.0 to 6.0
|
2 hour
Interval 1.0 to 4.0
|
—
|
—
|
|
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 28
|
—
|
—
|
2 hour
Interval 1.0 to 4.0
|
2 hour
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: Pharmacokinetic Population
τ = 12 hours for BID dosing and 24 hours for QD dosing. Day 28 is only for Part II.
Outcome measures
| Measure |
Part I: INDV-2000 100 mg QD
n=9 Participants
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=9 Participants
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 Participants
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 1, AUC0-τ
|
5800 hour*ng/mL
Geometric Coefficient of Variation 64.4
|
4760 hour*ng/mL
Geometric Coefficient of Variation 31.8
|
9460 hour*ng/mL
Geometric Coefficient of Variation 34.7
|
11900 hour*ng/mL
Geometric Coefficient of Variation 44.9
|
—
|
—
|
|
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 7, AUC0-τ
|
5660 hour*ng/mL
Geometric Coefficient of Variation 56.8
|
5570 hour*ng/mL
Geometric Coefficient of Variation 26.7
|
8930 hour*ng/mL
Geometric Coefficient of Variation 43.2
|
12000 hour*ng/mL
Geometric Coefficient of Variation 43.2
|
—
|
—
|
|
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Day 28, AUC0-τ
|
—
|
—
|
11600 hour*ng/mL
Geometric Coefficient of Variation 42.0
|
12700 hour*ng/mL
Geometric Coefficient of Variation 31.4
|
—
|
—
|
Adverse Events
Part I: INDV-2000 100 mg QD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part I: INDV-2000 100 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: Placebo (Pooled)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part II: INDV-2000 200 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part II: INDV-2000 400 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part II: Placebo (Pooled)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part III: INDV-2000 400 mg BID + SUBOXONE SL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I: INDV-2000 100 mg QD
n=9 participants at risk
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=6 participants at risk
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
n=6 participants at risk
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
Part III: INDV-2000 400 mg BID + SUBOXONE SL
n=16 participants at risk
A single cohort of treatment seeking participants with opioid use disorder (OUD) received SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants then received SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days, followed by INDV-2000 dosing alone for 4 days.
INDV-2000: Two 200 mg/capsule for oral administration
SUBOXONE® sublingual film: Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
Other adverse events
| Measure |
Part I: INDV-2000 100 mg QD
n=9 participants at risk
Healthy volunteers received INDV-2000 once daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: INDV-2000 100 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 7 days.
INDV-2000: 100 mg/capsule for oral administration
|
Part I: Placebo (Pooled)
n=6 participants at risk
Healthy volunteers received placebo either once daily or twice daily for 7 days.
Placebo: Capsule for oral administration
|
Part II: INDV-2000 200 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: One 200 mg/capsule for oral administration
|
Part II: INDV-2000 400 mg BID
n=9 participants at risk
Healthy volunteers received INDV-2000 twice daily for 28 days.
INDV-2000: Two 200 mg/capsule for oral administration
|
Part II: Placebo (Pooled)
n=6 participants at risk
Healthy volunteers received placebo twice daily for 28 days.
Placebo: Either one or two capsules for oral administration
|
Part III: INDV-2000 400 mg BID + SUBOXONE SL
n=16 participants at risk
A single cohort of treatment seeking participants with opioid use disorder (OUD) received SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants then received SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days, followed by INDV-2000 dosing alone for 4 days.
INDV-2000: Two 200 mg/capsule for oral administration
SUBOXONE® sublingual film: Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
55.6%
5/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
33.3%
2/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
88.9%
8/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
66.7%
6/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
22.2%
2/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Nervous system disorders
Dizzines
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
22.2%
2/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
General disorders
Vessel puncture site pain
|
22.2%
2/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Dental paraesthesia
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Injury, poisoning and procedural complications
Skin lacerations
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
General disorders
Fatigue
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
22.2%
2/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Feces discolored
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Investigations
Amylase increased
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
16.7%
1/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
11.1%
1/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/9 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
0.00%
0/6 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
6.2%
1/16 • From first dose of study drug up to 7 days after last dose (up to 14 days in Part I and 35 days in Part II). From first dose of INDV-2000 up to 7 days after last dose (up to 18 days) in Part III.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place