Trial Outcomes & Findings for Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants (NCT NCT06988423)
NCT ID: NCT06988423
Last Updated: 2026-03-18
Results Overview
CRS3123 PK parameters (AUC0-t, AUC0-inf, Cmax) values plotted against food status. Note: no food-effect is assumed if the 90% CI for the ratio of geometric means (B (fed)/A (fasted), based on least-squares means from the ANOVA of the ln-transformed CRS3123 AUC0-inf (or AUC0-t) AND Cmax, is within 80.00% to 125.00% for CRS3123.
COMPLETED
PHASE1
17 participants
Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
2026-03-18
Participant Flow
Participant milestones
| Measure |
Sequence 1 (AB)
Treatment A: 1x 200 mg CRS3123 administered under fasted conditions.
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions.
Participants in Sequence 1 received a single oral CRS3123 capsule of 200 mg dose on Day 1 under fasted conditions and Day 6 under fed conditions.
|
Sequence 2 (BA)
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions.
Treatment A: 1x 200 mg CRS3123 administered under fasted conditions.
Participants in Sequence 2 received a single oral CRS3123 capsule of 200 mg dose on Day 1 under fed conditions and Day 6 under fasted conditions.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Sequence 1 (AB)
n=9 Participants
Treatment A: 1x 200 mg CRS3123 administered under fasted conditions.
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions.
Participants in Sequence 1 received a single oral CRS3123 capsule of 200 mg dose on Day 1 under fasted conditions and Day 6 under fed conditions.
|
Sequence 2 (BA)
n=8 Participants
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions.
Treatment A: 1x 200 mg CRS3123 administered under fasted conditions.
Participants in Sequence 2 received a single oral CRS3123 capsule of 200 mg dose on Day 1 under fed conditions and Day 6 under fasted conditions.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 Years
n=110 Participants
|
33.5 Years
n=114 Participants
|
37 Years
n=224 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
9 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
8 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=110 Participants
|
8 Participants
n=114 Participants
|
17 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=110 Participants
|
6 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=110 Participants
|
8 participants
n=114 Participants
|
17 participants
n=224 Participants
|
|
Height
|
162 cm
n=110 Participants
|
167 cm
n=114 Participants
|
163 cm
n=224 Participants
|
|
Weight
|
69.2 kg
n=110 Participants
|
75.8 kg
n=114 Participants
|
69.7 kg
n=224 Participants
|
|
BMI
|
25.5 kg/m^2
n=110 Participants
|
26.6 kg/m^2
n=114 Participants
|
26.1 kg/m^2
n=224 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Statistical Population: All participants from the PK population and who did not experience any significant protocol deviations or other circumstances to exclude the participant from the PK statistical analysis.
CRS3123 PK parameters (AUC0-t, AUC0-inf, Cmax) values plotted against food status. Note: no food-effect is assumed if the 90% CI for the ratio of geometric means (B (fed)/A (fasted), based on least-squares means from the ANOVA of the ln-transformed CRS3123 AUC0-inf (or AUC0-t) AND Cmax, is within 80.00% to 125.00% for CRS3123.
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
n=16 Participants
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax
|
123.2 Ratio
Interval 97.7 to 155.5
|
129.9 Ratio
Interval 107.4 to 157.0
|
64.9 Ratio
Interval 51.6 to 81.6
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions
|
1885.5 h*ng/mL
Geometric Coefficient of Variation 49.8
|
1431.8 h*ng/mL
Geometric Coefficient of Variation 57.9
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions.
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=14 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions.
|
1960.5 h*ng/mL
Geometric Coefficient of Variation 44.6
|
1616.8 h*ng/mL
Geometric Coefficient of Variation 60.7
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Maximal observed concentration under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions
|
227.9 ng/mL
Geometric Coefficient of Variation 44.6
|
349.9 ng/mL
Geometric Coefficient of Variation 43.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Time when the maximal concentration is observed under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions
|
5.0 h
Interval 3.0 to 8.0
|
1.5 h
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions
|
1 h
Interval 0.5 to 2.5
|
0 h
Interval 0.0 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Terminal elimination half-life under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions
|
5.5 h
Interval 4.2 to 12.6
|
8.0 h
Interval 2.4 to 15.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Terminal elimination rate constant under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions
|
0.13 /h
Interval 0.06 to 0.17
|
0.09 /h
Interval 0.04 to 0.29
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Apparent clearance under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=14 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions
|
106.2 L/h
Interval 56.9 to 224.8
|
120.4 L/h
Interval 51.1 to 351.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Apparent volume of distribution under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=14 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions
|
951.2 L
Interval 403.8 to 2236.2
|
1130.7 L
Interval 475.8 to 1976.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Time when the maximal concentration is observed under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
|
5.0 h
Interval 4.0 to 12.0
|
2.0 h
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=16 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
|
1.0 h
Interval 0.0 to 2.5
|
0.0 h
Interval 0.0 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Terminal elimination half-life under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=14 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
|
5.1 h
Interval 3.4 to 12.3
|
6.4 h
Interval 3.5 to 17.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6Population: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).
Terminal elimination rate constant under fasted vs fed conditions
Outcome measures
| Measure |
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=14 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=15 Participants
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Cmax Ratio (Treatment B/Treatment A)
Cmax: maximal observed concentration
Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions
Treatment B: 1 x 200 mg CRS3123 administered under fed conditions
|
|---|---|---|---|
|
Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
|
0.1 /h
Interval 0.1 to 0.2
|
0.1 /h
Interval 0.0 to 0.2
|
—
|
Adverse Events
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions
n=17 participants at risk
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
|
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions
n=17 participants at risk
A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.
|
|---|---|---|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
11.8%
2/17 • Number of events 2 • Screening (Day -28) through Day 11
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Investigations
Red blood cells urine positive
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Blood pressure diastolic decreased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Blood pressure systolic decreased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Blood pressure systolic increased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Investigations
Heart rate increased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Protein total decreased
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
|
Investigations
Respiratory rate increased
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Screening (Day -28) through Day 11
|
5.9%
1/17 • Number of events 1 • Screening (Day -28) through Day 11
|
Additional Information
Lou Boccumini, Vice President, Clinical Development
Crestone, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee PI's right to publish study data is subject to Sponsor's rights to publish, with no time period pre-agreed.
- Publication restrictions are in place
Restriction type: OTHER