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| Name | Class |
|---|---|
| Cocrystal Pharma Australia Pty Ltd. | UNKNOWN |
| Linear Clinical Research | INDUSTRY |
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CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts.
Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug.
Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD cohort 1A | Experimental | first dose level with 6 active and 2 placebo healthy participants |
|
| SAD cohort 1B | Experimental | second dose level with 6 active and 2 placebo healthy participants |
|
| SAD cohort 1C | Experimental | third dose level with 12 active and 2 placebo healthy participants; food-effect cohort |
|
| SAD cohort 1D | Experimental | fourth dose level with 6 active and 2 placebo healthy participants |
|
| MAD cohort 2A | Experimental | first dose level with 6 active and 2 placebo healthy participants dose x 14 days |
|
| MAD cohort 2B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-42344 | Drug | CC-42344 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event. | Up to 16 days |
| Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant laboratory abnormalities was reported. | Up to 16 days |
| Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Number of participants with clinically significant changes from baseline in vital signs was reported | Up to 16 days |
| Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs) | Number of participants with clinically significant changes from baseline in ECG was reported | Up to 16 days |
| Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event. | Up to 21 days |
| Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 | Cmax was evaluated from the PK samples collected. | Day 1: -0.5, 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 dose |
| Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 |
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Inclusion Criteria (main):
Exclusion Criteria (main):
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| Name | Affiliation | Role |
|---|---|---|
| Sam Salman, MD | Linear Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
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Recruitment Details: 2-part study Part 1 single-ascending dose (SAD) included Cohorts 1A, 1B, 1C, and 1D. Part 2, the multiple-ascending dose (MAD), included cohorts 1A, 2B, 2C, 2D, and 2E.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1A - 100mg CC-42344 | Participants received a single oral dose of 100 milligrams (mg) of CC42344 or a placebo on day 1. |
| FG001 | Cohort 1A - Placebo | Participants received a single oral dose of placebo for CC42344 on day 1 |
| FG002 | Cohort 1B- 200mg CC-42344 | Participants received a single oral dose of 200 mg of CC42344 on day 1. |
| FG003 | Cohort 1B - Placebo | Participants received a single oral dose of placebo on day 1. |
| FG004 | Cohort 1C - 400mg CC-42344 | Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions. |
| FG005 | Cohort 1C - Placebo | Participants received a single oral dose of placebo on day 1, under fasted conditions, and on day 9, under fed conditions. |
| FG006 | Cohort 1C-2 - 400mg CC-42344 | Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions. |
| FG007 | Cohort 1D - 800mg CC-42344 | Participants received a single oral dose of 800 mg of CC42344 on day 1. |
| FG008 | Cohort 1D - Placebo | Participants received a single oral dose of placebo on day 1. |
| FG009 | Cohort 2A - 50mg CC-42344 | Participants received 50 mg CC-42344 orally once daily (QD) from day 1 to day 14. |
| FG010 | Cohort 2A - Placebo | Participants received placebo orally once daily (QD) from day 1 to day 14. |
| FG011 | Cohort 2B - 100mg CC-42344 | Participants received 100 mg CC-42344 QD from day 1 to day 14. |
| FG012 | Cohort 2B - Placebo | Participants received placebo QD from day 1 to day 14. |
| FG013 | Cohort 2C - 200mg CC-42344 | Participants received 200 mg CC-42344 QD from day 1 to day 14. |
| FG014 | Cohort 2C - Placebo | Participants received placebo QD from day 1 to day 14. |
| FG015 | Cohort 2D - 400mg CC-42344 QD | Participants received 400 mg CC-42344 QD from day 1 to day 5. |
| FG016 | Cohort 2D - Placebo | Participants received placebo QD from day 1 to day 5. |
| FG017 | Cohort 2E - 400mg CC-42344 BID | Participants received 400 mg CC-42344 twice daily (BID) from day 1 to day 5. |
| FG018 | Cohort 2E - Placebo | Participants received placebo twice daily (BID) from day 1 to day 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The safety population included all participants who received at least one dose of study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 100mg CC-42344 - Fasted | Participants received a single oral dose of 100 milligrams (mg) of CC42344 on day 1. |
| BG001 | Part 1 200mg CC-42344 - Fasted | Participants received a single oral dose of 200 mg of CC42344 on day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (Years) | The safety population included all participants who received at least one dose of study treatment |
| 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 | Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event. | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 16 days |
|
Up to 21 days
Safety Population
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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 | Part 1 SAD - 100mg CC-42344 - Fasted | Participants received a single oral dose of 100 milligrams (mg) of CC42344 on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Huang, MD, PhD, Chief Medical Officer | Cocrystal Pharma | 936-577-5770 | dhuang@cocrystalpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2022 | Dec 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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4 cohorts for SAD, with food cohort; 5 cohorts for MAD; 6 active and 2 placebo per cohort; 6 additional active in food cohort
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active and placebo capsules identical visually.
second dose level with 6 active and 2 placebo healthy participants dose x 14 days |
|
| MAD cohort 2C | Experimental | third dose level with 6 active and 2 placebo healthy participants dose x 14 days |
|
| MAD cohort 2D | Experimental | forth dose level with 6 active and 2 placebo healthy participants dose x 5 days |
|
| MAD cohort 2E | Experimental | forth dose level with 6 active and 2 placebo healthy participants dose x 5 days |
|
|
| Placebo | Drug | Placebo capsules |
|
Number of participants with clinically significant laboratory abnormalities was reported
| Up to 21 days |
| Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Number of participants with clinically significant changes from baseline in vital signs was reported | Up to 21 days |
| Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs) | Number of participants with clinically significant changes from baseline in ECGs was reported. | Up to 14 days |
Tmax was evaluated from the PK samples collected. |
| Day 1: -0.5, 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 dose |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 | AUC0-t was evaluated from the PK samples collected. | Day 1: -0.5, 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 dose |
| Part 1 SAD: Elimination Rate Constant (λz) of CC-42344 | λz was evaluated from the PK samples collected. | Day 1: -0.5, 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 dose |
| Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344 | t1/2 was evaluated from the PK samples collected. | Day 1: -0.5, 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 dose |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 | AUC0-inf was evaluated from the PK samples collected. | Day 1: -0.5, 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 dose |
| Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed | Cmax was evaluated from the PK samples collected. | Day 1 and Day 9: -0.5, 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 dose |
| Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed | Tmax was evaluated from the PK samples collected. | Day 1 and Day 9: -0.5, 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 dose |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed | AUC0-t was evaluated from the PK samples collected. | Day 1 and Day 9: -0.5, 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 dose |
| Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed | AUC0-inf was evaluated from the PK samples collected. | Day 1 and Day 9: -0.5, 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 dose |
| Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344 | Cmax was evaluated from the PK samples collected. | Day 1: Pre-dose through 24 h post-dose, Day 5: Pre-dose through 96 h post-dose, and Day 14: Pre-dose through 96 h post-dose |
| Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 | Tmax was evaluated from the PK samples collected. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24 h post-dose Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, |
| Part 2 MAD: Elimination Rate Constant (λz) of CC-42344 | λz was evaluated from the PK samples collected. | Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose |
| Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344 | T1/2 was evaluated from the PK samples collected. | Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose |
| Randomized not treated |
|
| BG002 | Part 1 400mg CC-42344 Fasted / Fed | Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions. |
| BG003 | Part 1 800mg CC-42344 - Fasted | Participants received a single oral dose of 800 mg of CC42344 on day 1. |
| BG004 | Part 1 SAD - Placebo | Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1 and under fed conditions on Day 9 |
| BG005 | Part 2 MAD - 50mg CC-42344 - Fed | Participants received 50 mg CC-42344 orally once daily (QD) from day 1 to day 14. |
| BG006 | Part 2 MAD - 100mg CC-42344 - Fed | Participants received 100 mg CC-42344 QD from day 1 to day 14. |
| BG007 | Part 2 MAD - 200mg CC-42344 -Fed | Participants received 200 mg CC-42344 QD from day 1 to day 14. |
| BG008 | Part 2 MAD - 400mg CC-42344 QD - Fed | Participants received 400 mg CC-42344 QD from day 1 to day 5. |
| BG009 | Part 2 MAD - 400mg CC-42344 BID - Fed | Participants received 400 mg CC-42344 BID from day 1 to day 5. |
| BG010 | Part 2 MAD - Placebo - Fed | Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 1 to day 5 or day 1 to day 14. |
| BG011 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender | The safety population included all participants who received at least one dose of study treatment | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity | The safety population included all participants who received at least one dose of study treatment | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race | The safety population included all participants who received at least one dose of study treatment | Count of Participants | Participants |
|
Participants received a single oral dose of 200 mg of CC42344 on day 1. |
| OG002 | Part 1 SAD - 400mg CC-42344 - Fasted | Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions. |
| OG003 | Part 1 SAD - 400mg CC-42344 - Fed | Participants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions, and on day 9, under fed conditions. |
| OG004 | Part 1 SAD - 800mg CC-42344 Fasted | Participants received a single oral dose of 800 mg of CC42344 on day 1. |
| OG005 | Part 1 SAD - Placebo Fasted | Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on day 1 |
| OG006 | Part 1 SAD - Placebo - Fed | Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on day 9 |
|
|
| Primary | Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant laboratory abnormalities was reported. | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 16 days |
|
|
|
| Primary | Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Number of participants with clinically significant changes from baseline in vital signs was reported | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 16 days |
|
|
|
| Primary | Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs) | Number of participants with clinically significant changes from baseline in ECG was reported | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 16 days |
|
|
|
| Secondary | Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 | Cmax was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: -0.5, 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 dose |
|
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|
| Secondary | Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 | Tmax was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Median | Full Range | Hours | Day 1: -0.5, 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 dose |
|
|
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| Secondary | Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 | AUC0-t was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (hr*ng/mL) | Day 1: -0.5, 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 dose |
|
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| Secondary | Part 1 SAD: Elimination Rate Constant (λz) of CC-42344 | λz was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Day 1: -0.5, 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 dose |
|
|
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| Secondary | Part 1 SAD: Terminal Elimination Half-life (t1/2) of CC-42344 | t1/2 was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour | Day 1: -0.5, 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 dose |
|
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| Primary | Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE) | AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event. | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 21 days |
|
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| Primary | Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant laboratory abnormalities was reported | Number of participants with clinically significant laboratory abnormalities was reported | Posted | Number | Participants | Up to 21 days |
|
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| Primary | Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Number of participants with clinically significant changes from baseline in vital signs was reported | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 21 days |
|
|
|
| Primary | Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs) | Number of participants with clinically significant changes from baseline in ECGs was reported. | All subjects from the ITT Analysis Set who received at least one dose of study drug (CC-42344 or placebo) | Posted | Number | Participants | Up to 14 days |
|
|
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| Secondary | Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 | AUC0-inf was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1: -0.5, 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 dose |
|
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| Secondary | Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed | Cmax was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 and Day 9: -0.5, 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 dose |
|
|
|
| Secondary | Part 1 SAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 - Fasted vs Fed | Tmax was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Median | Full Range | Hours | Day 1 and Day 9: -0.5, 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 dose |
|
|
|
| Secondary | Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed | AUC0-t was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (hr*ng/mL) | Day 1 and Day 9: -0.5, 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 dose |
|
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| Secondary | Part 1 SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed | AUC0-inf was evaluated from the PK samples collected. | PK Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. After the SAD cohorts were completed, it was found that the Cohort 1C PK data were not interpretable due to issues with the execution of the assay for plasma CC-42344 levels. Therefore, an additional 6 subjects were enrolled and treated with 400 mg CC-42344 to generate usable PK and food-effect data. This is Cohort 1C-2 | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 and Day 9: -0.5, 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 dose |
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| Secondary | Part 2 MAD: Maximum Plasma Concentration (Cmax) of CC-42344 | Cmax was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: Pre-dose through 24 h post-dose, Day 5: Pre-dose through 96 h post-dose, and Day 14: Pre-dose through 96 h post-dose |
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| Secondary | Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344 | Tmax was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. | Posted | Median | Full Range | Hours | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24 h post-dose Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, |
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| Secondary | Part 2 MAD: Elimination Rate Constant (λz) of CC-42344 | λz was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hr | Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose |
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| Secondary | Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344 | T1/2 was evaluated from the PK samples collected. | Pharmacokinetic (PK) Analysis Set - Subjects in the Safety Analysis Set who received CC-42344 as planned and had interpretable PK data. Participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose |
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| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Part 1 SAD 200mg CC-42344 - Fasted | Participants received a single oral dose of 200 mg of CC42344 on day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Part 1 SAD - 400mg CC-42344 - Fasted | tParticipants received a single oral dose of 400 mg of CC42344 on day 1, under fasted conditions. | 0 | 12 | 0 | 12 | 6 | 12 |
| EG003 | Part 1 SAD - 400mg CC-42344 - Fed | Participants received a single oral dose of 400 mg of CC42344 on day 9, under fed conditions. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG004 | Part 1 SAD - 800mg CC-42344 Fasted | Participants received a single oral dose of 800 mg of CC42344 on day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | Part 1 SAD - Placebo Fasted | Participants received a single oral dose of a placebo-matched CC-42344 under fasted conditions on Day 1 | 0 | 8 | 0 | 8 | 4 | 8 |
| EG006 | Part 1 SAD - Placebo - Fed | Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions on Day 9 | 0 | 2 | 0 | 2 | 1 | 2 |
| EG007 | Part 2 MAD - 50mg CC-42344 -Fed | Participants received 50 mg CC-42344 once daily (QD) from day 1 to day 14. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG008 | Part 2 MAD - 100mg CC-42344 -Fed | Participants received 100 mg CC-42344 QD from day 1 to day 14. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG009 | Part 2 MAD - 200mg CC-42344 -Fed | Participants received 200 mg CC-42344 QD from day 1 to day 14. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG010 | Part 2 MAD - 400mg CC-42344 QD - Fed | Participants received 400 mg CC-42344 QD from day 1 to day 5. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG011 | Part 2 MAD - 400mg CC-42344 BID - Fed | Participants received 400 mg CC-42344 twice daily (BID) from day 1 to day 5. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG012 | Part 2 MAD - Placebo - Fed | Participants received a single oral dose of a placebo-matched CC-42344 under fed conditions from day 1 to day 5 or day 1 to day 14 | 0 | 10 | 0 | 10 | 8 | 10 |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Muscle contractions involuntary | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Sensory disturbance | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Anal Fissure | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Change of Bowel habit | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Early satiety | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vascular access site dermatitis | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Vascular access site bruising | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Palate injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Vascular access site swelling | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
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| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Eyelid irritation | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Alcoholic hangover | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vulvovaginal rash | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Superficial vein thrombosis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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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.
| Last dose (Day 5 or 14) |
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| Last dose (Day 5 or 14) |
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