Trial Outcomes & Findings for CDI-988 Safety Study in Healthy Participants (NCT NCT05977140)
NCT ID: NCT05977140
Last Updated: 2026-08-19
Results Overview
number of participants with clinically significant laboratory abnormalities
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
94 participants
Primary outcome timeframe
Up to 17 days
Results posted on
2026-08-19
Participant Flow
Part 1 single-ascending dose (SAD) included Cohorts 1A, 1B, 1C, 1D, 1E and 1F. Part 2, the multiple-ascending dose (MAD), included cohorts 1A, 2B, 2C, 2D, 2E, Cohort 2F.
Participant milestones
| Measure |
MAD Cohort 2E
Participants received 1200 mg CDI-988 twice daily (BID) from day 1 to day 5 fasted.
|
MAD Cohort 2F
Participants received 1200 mg CDI-988 twice daily (BID) from day 1 to day 5 following a standard meal.
|
Part 2 MAD Placebo
Participants received either a QD or a BID oral dose of a placebo-matched CDI-988 on day 1 to day 5 or day 1 to day 10
|
MAD Cohort 2D
Participants received 1200 mg CDI-988 QD from day 1 to day 5 following a standard meal.
|
SAD Cohort 1A
Participants received a single oral dose of 100 mg of CDI-988 on day 1.
|
SAD Cohort 1B
Participants received a single oral dose of 200 mg of CDI-988 on day 1.
|
SAD Cohort 1C
Participants received a single oral dose of 400 mg of CDI-988 on day 1, under fasted conditions, and on day 9, under fed conditions (high fat meal).
|
SAD Cohort 1D
Participants received a single oral dose of 600 mg of CDI-988 on day 1.
|
SAD Cohort 1E
Participants received a single oral dose of 100 mg of CDI-988 on day 1, under fasted conditions, and on day 9, under fed conditions (standard meal).
|
SAD Cohort 1F
Participants received a single oral dose of 1200 mg of CDI-988 n day 1, under fasted conditions, and on day 9, under fed conditions (standard meal).
|
Part 1 SAD Placebo
Participants received a single oral dose of a placebo-matched CDI-988 under fasted conditions on day 1 and some participants received a dose under fed conditions on day 9
|
MAD Cohort 2A
Participants received 200 mg CDI-988 orally once daily (QD) from day 1 to day 10 following a standard meal.
|
MAD Cohort 2B
Participants received 400 mg CDI-988 QD from day 1 to day 10 following a standard meal.
|
MAD Cohort 2C
Participants received 800 mg CDI-988 QD from day 1 to day 10 following a standard meal.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The safety population included all participants who received at least one dose of study treatment
Baseline characteristics by cohort
| Measure |
Part 1 SAD 100mg CDI-988 Fasted
n=6 Participants
Participants received a single oral dose of 100 mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD 100mg CDI-988 Fasted/Fed (Standard Meal)
n=6 Participants
Participants received a single oral dose of 100 mg of CDI-988 on day 1, under fasted conditions, and on day 9, under fed conditions (standard meal).
|
Part 1 SAD 200mg CDI-988 Fasted
n=6 Participants
Participants received a single oral dose of 200 mg of CDI-988 on day 1.
|
Part 1 SAD 400mg CDI-988 Fasted/Fed (High Fat Meal)
n=6 Participants
Participants received a single oral dose of 400 mg of CDI-988 on day 1, under fasted conditions, and on day 9, under fed conditions (high fat meal).
|
Part 1 SAD 600mg CDI-988 Fasted
n=6 Participants
Participants received a single oral dose of 600 mg of CDI-988 on day 1.
|
Part 1 SAD 1200mg CDI-988 Fasted/Fed (Standard Meal)
n=6 Participants
Participants received a single oral dose of 1200 mg of CDI-988 or a placebo on day 1, under fasted conditions, and on day 9, under fed conditions (standard meal).
|
Part 1 SAD - Placebo
n=10 Participants
All participants received a single oral dose of a placebo-matched CDI-988 under fasted conditions on day 1 and some participants received a dose under fed conditions on day 9
|
Part 2 MAD 200mg CDI-988 QD (Standard Meal)
n=6 Participants
Participants received 200 mg CDI-988 orally once daily (QD) from day 1 to day 10 following a standard meal.
|
Part 2 MAD 400mg CDI-988 QD (Standard Meal)
n=6 Participants
Participants received 400 mg CDI-988 QD from day 1 to day 10 following a standard meal.
|
Part 2 MAD 800mg CDI-988 QD (Standard Meal)
n=6 Participants
Participants received 800 mg CDI-988 QD from day 1 to day 10 following a standard meal.
|
Part 2 MAD 1200mg CDI-988 QD (Standard Meal)
n=6 Participants
Participants received 1200 mg CDI-988 QD from day 1 to day 5 following a standard meal.
|
Part 2 MAD 1200mg CDI-988 BID Fasted
n=6 Participants
Participants received 1200 mg CDI-988 twice daily (BID) from day 1 to day 5 fasted.
|
Part 2 MAD 1200mg CDI-988 BID (Standard Meal)
n=6 Participants
Participants received 1200 mg CDI-988 (BID) from day 1 to day 5 following a standard meal.
|
Part 2 MAD - Placebo
n=12 Participants
Participants received either a QD or a BID oral dose of a placebo-matched CDI-988 on day 1 to day 5 or day 1 to day 10.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.53 years
STANDARD_DEVIATION 5.27 • n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.2 years
STANDARD_DEVIATION 7.87 • n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.57 years
STANDARD_DEVIATION 6.60 • n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
35.13 years
STANDARD_DEVIATION 10.52 • n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
27.40 years
STANDARD_DEVIATION 5.68 • n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
26.10 years
STANDARD_DEVIATION 5.28 • n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
32.45 years
STANDARD_DEVIATION 12.30 • n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.20 years
STANDARD_DEVIATION 7.26 • n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.87 years
STANDARD_DEVIATION 4.83 • n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
32.13 years
STANDARD_DEVIATION 5.99 • n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
28.77 years
STANDARD_DEVIATION 7.97 • n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
29.77 years
STANDARD_DEVIATION 5.79 • n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
27.97 years
STANDARD_DEVIATION 5.79 • n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.62 years
STANDARD_DEVIATION 5.36 • n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
30.12 years
STANDARD_DEVIATION 7.14 • n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Sex: Female, Male
Female
|
4 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
8 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
48 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Sex: Female, Male
Male
|
2 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
46 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
27 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
White
|
5 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
56 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
18 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
6 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
5 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
4 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
7 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
73 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=102 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=400 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=1389 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
2 Participants
n=44 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=97 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
1 Participants
n=23 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=748 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=122 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
0 Participants
n=31 Participants • The safety population included all participants who received at least one dose of study treatment
|
3 Participants
n=30 Participants • The safety population included all participants who received at least one dose of study treatment
|
PRIMARY outcome
Timeframe: Up to 17 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-9882 or placebo)
number of participants with treatment-emergent adverse events
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
n=6 Participants
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
n=4 Participants
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
n=12 Participants
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=12 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=10 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
11 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 17 daysPopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)
number of participants with clinically significant laboratory abnormalities
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
n=6 Participants
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
n=4 Participants
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
n=12 Participants
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=12 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=10 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 7 days after last dosePopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)
number of participants with clinically significant changes from baseline in vital signs
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
n=6 Participants
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
n=4 Participants
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
n=12 Participants
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=12 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=10 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 7 days after last dosePopulation: All subjects from the ITT Analysis Set who received at least one dose of study drug (CDI-988 or placebo)
number of participants with clinically significant changes from baseline in ECGs
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
n=6 Participants
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
n=4 Participants
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
n=6 Participants
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
n=12 Participants
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=12 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=10 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ECGs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
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: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
Cmax was evaluated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 SAD Maximum Plasma Concentration (Cmax)
|
—
|
153 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 63
|
2747 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
2480 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
61 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 64
|
176 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 91
|
544 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
536 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
1074 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
Tmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 SAD Time of Maximum Plasma Concentration (Tmax)
|
—
|
6.0 Hours
Interval 2.5 to 6.0
|
4.0 Hours
Interval 2.5 to 6.0
|
4.9 Hours
Interval 3.5 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 Hours
Interval 1.5 to 2.5
|
2.8 Hours
Interval 2.0 to 3.5
|
4.0 Hours
Interval 2.0 to 4.0
|
3.5 Hours
Interval 2.5 to 4.0
|
4.0 Hours
Interval 2.5 to 4.0
|
4.0 Hours
Interval 0.9 to 4.2
|
SECONDARY outcome
Timeframe: pre dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
AUC0-t was evaluated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 SAD Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to t (AUC0-t) of CDI-988
|
—
|
782 hour*nanogram per milliliter
Geometric Coefficient of Variation 43
|
16233 hour*nanogram per milliliter
Geometric Coefficient of Variation 42
|
14683 hour*nanogram per milliliter
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
251 hour*nanogram per milliliter
Geometric Coefficient of Variation 45
|
332 hour*nanogram per milliliter
Geometric Coefficient of Variation 60
|
886 hour*nanogram per milliliter
Geometric Coefficient of Variation 127
|
2644 hour*nanogram per milliliter
Geometric Coefficient of Variation 19
|
2213 hour*nanogram per milliliter
Geometric Coefficient of Variation 52
|
5450 hour*nanogram per milliliter
Geometric Coefficient of Variation 61
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data. Participants with available data were analyzed.
λz was evaluated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 SAD Elimination Rate Constant (Lambda Z)
|
—
|
0.1 1/hour
Geometric Coefficient of Variation 17
|
0.1 1/hour
Geometric Coefficient of Variation 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.4 1/hour
Geometric Coefficient of Variation 28
|
0.4 1/hour
Geometric Coefficient of Variation 16
|
0.3 1/hour
Geometric Coefficient of Variation 32
|
0.2 1/hour
Geometric Coefficient of Variation 53
|
0.1 1/hour
Geometric Coefficient of Variation 26
|
0.4 1/hour
Geometric Coefficient of Variation 1
|
SECONDARY outcome
Timeframe: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dosePopulation: PK Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data. Participants with available data were analyzed.
t1/2 was evaluated from the PK samples collected.
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 SAD Terminal Elimination Half-life (t1/2)
|
—
|
8.2 Hour
Geometric Coefficient of Variation 17
|
10.4 Hour
Geometric Coefficient of Variation 6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.8 Hour
Geometric Coefficient of Variation 28
|
1.7 Hour
Geometric Coefficient of Variation 16
|
2.5 Hour
Geometric Coefficient of Variation 32
|
3.0 Hour
Geometric Coefficient of Variation 53
|
7.5 Hour
Geometric Coefficient of Variation 26
|
1.9 Hour
Geometric Coefficient of Variation 1
|
SECONDARY outcome
Timeframe: Day 1, Day 5 and Day 10: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48h post-dosePopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
Cmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
311 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
508 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
1726 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 59
|
2732 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
1637 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
1196 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
|
Part 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988
Last Dose (Day 5 or Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
344 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
759 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
1272 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
2146 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
1804 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
632 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53
|
SECONDARY outcome
Timeframe: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 hPopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
Tmax was evaluated from the PK samples collected.
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.7 Hours
Interval 1.0 to 3.5
|
3.7 Hours
Interval 3.0 to 5.9
|
3.9 Hours
Interval 2.4 to 5.9
|
5.8 Hours
Interval 3.5 to 5.9
|
3.5 Hours
Interval 3.4 to 23.2
|
5.9 Hours
Interval 3.0 to 23.5
|
|
Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988
Last Dose (Day 5 or Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 Hours
Interval 1.0 to 3.5
|
2.7 Hours
Interval 1.5 to 3.5
|
3.2 Hours
Interval 2.1 to 6.0
|
5.8 Hours
Interval 4.0 to 5.9
|
4.0 Hours
Interval 2.5 to 8.1
|
3.0 Hours
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 hPopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data.
AUC0-t was calculated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1475 h*ng/mL
Geometric Coefficient of Variation 32
|
2501 h*ng/mL
Geometric Coefficient of Variation 34
|
8435 h*ng/mL
Geometric Coefficient of Variation 56
|
13980 h*ng/mL
Geometric Coefficient of Variation 25
|
12209 h*ng/mL
Geometric Coefficient of Variation 61
|
9582 h*ng/mL
Geometric Coefficient of Variation 116
|
|
Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988
Last Dose (Day 5 or Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1463 h*ng/mL
Geometric Coefficient of Variation 30
|
3787 h*ng/mL
Geometric Coefficient of Variation 24
|
7311 h*ng/mL
Geometric Coefficient of Variation 58
|
14114 h*ng/mL
Geometric Coefficient of Variation 38
|
11243 h*ng/mL
Geometric Coefficient of Variation 49
|
5292 h*ng/mL
Geometric Coefficient of Variation 34
|
SECONDARY outcome
Timeframe: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 hPopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data. Participants with available data were analyzed.
λz was evaluated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Elimination Rate Constant (λz) of CDI-988
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.4 1/h
Geometric Coefficient of Variation 8
|
0.2 1/h
Geometric Coefficient of Variation 32
|
0.2 1/h
Geometric Coefficient of Variation 1
|
NA 1/h
Geometric Coefficient of Variation NA
The elimination rate constant was not calculated because there was insufficient data in the log-linear phase to estimate lambda\_z for any participant.
|
NA 1/h
Geometric Coefficient of Variation NA
The elimination rate constant was not calculated because there was insufficient data in the log-linear phase to estimate lambda\_z for any participant.
|
NA 1/h
Geometric Coefficient of Variation NA
The elimination rate constant was not calculated because there was insufficient data in the log-linear phase to estimate lambda\_z for any participant.
|
|
Part 2 MAD: Elimination Rate Constant (λz) of CDI-988
Last Dose (Day 5 or Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.2 1/h
Geometric Coefficient of Variation 46
|
0 1/h
Geometric Coefficient of Variation 47
|
0.1 1/h
Geometric Coefficient of Variation 38
|
0.1 1/h
Geometric Coefficient of Variation 15
|
0 1/h
Geometric Coefficient of Variation 9
|
0 1/h
Geometric Coefficient of Variation 21
|
SECONDARY outcome
Timeframe: Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 hPopulation: Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CDI-988 as planned and had interpretable PK data. Participants with available data were analyzed.
T1/2 was evaluated from the PK samples collected
Outcome measures
| Measure |
Part 2 MAD CDI-988 800mg QD Fed
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
Part 1 SAD CDI-988 100mg Fasted
n=6 Participants
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 Participants
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 Participants
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 Participants
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 Participants
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=6 Participants
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988
Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.8 h
Geometric Coefficient of Variation 8
|
2.9 h
Geometric Coefficient of Variation 32
|
4.2 h
Geometric Coefficient of Variation 1
|
NA h
Geometric Coefficient of Variation NA
The half-life was not calculated because there was insufficient data in the log-linear phase to estimate t½ for any participant
|
NA h
Geometric Coefficient of Variation NA
The half-life was not calculated because there was insufficient data in the log-linear phase to estimate t½ for any participant
|
NA h
Geometric Coefficient of Variation NA
The half-life was not calculated because there was insufficient data in the log-linear phase to estimate t½ for any participant
|
|
Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988
Last Dose (Day 5 or Day 10)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.8 h
Geometric Coefficient of Variation 46
|
16.4 h
Geometric Coefficient of Variation 71
|
12.6 h
Geometric Coefficient of Variation 38
|
11.3 h
Geometric Coefficient of Variation 15
|
15.1 h
Geometric Coefficient of Variation 9
|
15.1 h
Geometric Coefficient of Variation 21
|
Adverse Events
Part 1 SAD CDI-988 100mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 200mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 400mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 600mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 1200mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 100mg Fed Day 9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 400mg Fed Day 9
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 SAD CDI-988 1200mg Fed Day 9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 SAD Placebo Fed on Day 9
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 200mg QD Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 400mg QD Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 800mg QD Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 1200mg QD Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 1200mg BID Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 MAD Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 SAD CDI-988 100mg Fasted
n=12 participants at risk
Participants received a single oral dose of 100 milligrams (mg) of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 200mg Fasted
n=6 participants at risk
Participants received a single oral dose of 200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 400mg Fasted
n=6 participants at risk
Participants received a single oral dose of 400mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 600mg Fasted
n=6 participants at risk
Participants received a single oral dose of 600mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD CDI-988 1200mg Fasted
n=6 participants at risk
Participants received a single oral dose of 1200mg of CDI-988 on day 1 under fasted conditions
|
Part 1 SAD Placebo
n=10 participants at risk
Participants received a single oral dose of placebo on day 1 under fasted conditions
|
Part 1 SAD CDI-988 100mg Fed Day 9
n=6 participants at risk
Participants received a single oral dose of 100mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 400mg Fed Day 9
n=6 participants at risk
Participants received a single oral dose of 400mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD CDI-988 1200mg Fed Day 9
n=6 participants at risk
Participants received a single oral dose of 1200mg of CDI-988 on day 9 under fed conditions
|
Part 1 SAD Placebo Fed on Day 9
n=4 participants at risk
Participants received a single oral dose of placebo on day 9 under fed conditions
|
Part 2 MAD CDI-988 200mg QD Fed
n=6 participants at risk
Participants received a single oral dose of 200mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 400mg QD Fed
n=6 participants at risk
Participants received a single oral dose of 400mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 800mg QD Fed
n=6 participants at risk
Participants received a single oral dose of 800mg of CDI-988 on days 1 through 10 under fed conditions
|
Part 2 MAD CDI-988 1200mg QD Fed
n=6 participants at risk
Participants received a single oral dose of 1200mg of CDI-988 on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg BID Fed
n=6 participants at risk
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fed conditions
|
Part 2 MAD CDI-988 1200mg CDI-988 BID Fasted
n=6 participants at risk
Participants received an oral dose of 1200mg of CDI-988 twice daily on days 1 through 5 under fasted conditions
|
Part 2 MAD Placebo
n=12 participants at risk
Participants received an oral dose of placebo either once daily for 10 days or twice daily for 5 days under fasted or fed conditions
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 2 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
50.0%
3/6 • Number of events 3 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
25.0%
3/12 • Number of events 3 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Injury, poisoning and procedural complications
Product use complaint
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Up to 17 days
Safety population
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
10.0%
1/10 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up to 17 days
Safety population
|
33.3%
2/6 • Number of events 2 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
33.3%
2/6 • Number of events 2 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
30.0%
3/10 • Number of events 4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
25.0%
1/4 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
33.3%
4/12 • Number of events 5 • Up to 17 days
Safety population
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
10.0%
1/10 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/12 • Up to 17 days
Safety population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
10.0%
1/10 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
2/12 • Number of events 2 • Up to 17 days
Safety population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
16.7%
1/6 • Number of events 1 • Up to 17 days
Safety population
|
33.3%
2/6 • Number of events 2 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/10 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/4 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
0.00%
0/6 • Up to 17 days
Safety population
|
8.3%
1/12 • Number of events 1 • Up to 17 days
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction exists to protect Cocrystal's confidential and proprietary information, to ensure data integrity, and to coordinate the accurate and timely public disclosure of trial results.
- Publication restrictions are in place
Restriction type: OTHER