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| ID | Type | Description | Link |
|---|---|---|---|
| 75N93019C00056 (DMID 25-0002) | Other Grant/Funding Number | NIAID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.
This study will assess the impact of a high-calorie and high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 in healthy adult participants when administered as a single oral capsule of 200 mg dose. Pharmacokinetics (PK) of a single dose of CRS3123 200 mg will be studied following administration to healthy participants under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: 1 x 200 mg CRS3123 capsule administered under fasted conditions | Experimental | 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 | Experimental | A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRS3123 200 mg capsule | Drug | CRS3123 200 mg capsule given as a single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax | 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. | 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 |
| Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions | Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions | 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 |
| Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions. | Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions. | 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 |
| Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions | Maximal observed concentration under fasted vs fed conditions | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions | Time when the maximal concentration is observed under fasted vs fed conditions | 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 |
| Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions |
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Inclusion Criteria:
Non-pregnant and non-lactating adults, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 64 years of age, with body mass index (BMI) > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males (as assigned at birth) and ≥ 45.0 kg for females (as assigned at birth), at the time of signing the informed consent.
Healthy as defined by:
Healthy females (as assigned at birth) of non-childbearing potential must be:
Sexually active females (as assigned at birth) of childbearing potential and non-sterile males (as assigned at birth) must be willing to use an acceptable contraceptive method throughout the study.
Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population: All participants who receive at least one dose of CRS3123.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax | 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. | 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. | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Ratio | 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 |
|
Screening (Day -28) through Day 11
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions | A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood bilirubin increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lou Boccumini, Vice President, Clinical Development | Crestone, Inc. | 609-900-5733 | lboccumini@crestonepharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2025 | Feb 5, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2025 | Mar 16, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2025 | May 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C541771 | REP 3123 |
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In each period, participants will receive Treatment A or Treatment B according to the randomization scheme:
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Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions |
| 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 |
| Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions | Terminal elimination half-life under fasted vs fed conditions | 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 |
| Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions | Terminal elimination rate constant under fasted vs fed conditions | 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 |
| Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions | Apparent clearance under fasted vs fed conditions | 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 |
| Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions | Apparent volume of distribution under fasted vs fed conditions | 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 |
| Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Time when the maximal concentration is observed under fasted vs fed conditions | 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 |
| Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions | 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 |
| Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Terminal elimination half-life under fasted vs fed conditions | 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 |
| Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Terminal elimination rate constant under fasted vs fed conditions | 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | cm |
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| Weight | Median | Full Range | kg |
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| BMI | Median | Full Range | kg/m^2 |
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| OG001 | AUC0-inf Ratio (Treatment B/Treatment A) | AUC0-inf: area under the concentration-time curve from time zero to infinity (extrapolated) Treatment A: 1 x 200 mg CRS3123 administered under fasting conditions Treatment B: 1 x 200 mg CRS3123 administered under fed conditions |
| OG002 | 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 |
|
|
| Primary | Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions | Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
|
|
| Primary | Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions. | Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions. | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
|
|
| Primary | Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions | Maximal observed concentration under fasted vs fed conditions | 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). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Secondary | Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions | Time when the maximal concentration is observed under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions | Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions | Terminal elimination half-life under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions | Terminal elimination rate constant under fasted vs fed conditions | 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). | Posted | Median | Full Range | /h | 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 |
|
|
|
| Secondary | Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions | Apparent clearance under fasted vs fed conditions | 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). | Posted | Median | Full Range | L/h | 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 |
|
|
|
| Secondary | Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions | Apparent volume of distribution under fasted vs fed conditions | 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). | Posted | Median | Full Range | L | 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 |
|
|
|
| Secondary | Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Time when the maximal concentration is observed under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Terminal elimination half-life under fasted vs fed conditions | 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). | Posted | Median | Full Range | h | 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 |
|
|
|
| Secondary | Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions | Terminal elimination rate constant under fasted vs fed conditions | 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). | Posted | Median | Full Range | /h | 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 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 5 |
| 17 |
| EG001 | Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions | A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions. | 0 | 17 | 0 | 17 | 6 | 17 |
| Blood glucose increased | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| Blood pressure diastolic decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Blood pressure systolic increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Protein total decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Respiratory rate increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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PI's right to publish study data is subject to Sponsor's rights to publish, with no time period pre-agreed.