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| Name | Class |
|---|---|
| Chroma Therapeutics | INDUSTRY |
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The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast. |
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| Treatment B | Experimental | Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHR-2797 | Drug | Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measurement | Report adverse events, vital signs, electrocardiograms, and clinical laboratory test. Averse events, clinical labs, and other safety variables will be analyzed descriptively for all sujects who recieve at least 1 dose of study drug. | 10 days |
| Pharmacokinetic Parameter | For each subject the following PK parameters will be calculated, whevever possible, based on the plasma concentrations of CHR-2797 and its metabolite CHR-79888:
| 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be summarized by presenting the number and percentages of subjects having any adverse event by MED DRA system organ class and preferred term, relationship to study drug and severity/CTCAE grade. All adverse events will be listed. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Stoltz, MD | Covance | Principal Investigator |
| Simran Singh, MS, GWCPM | CTI BioPharma | Study Chair |
| Bob Wright, PM | Covance | Study Director |
| Jack Singer, MD | CTI BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| C531970 | tosedostat |
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| CHR-2797 | Drug | Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal. -------------------------------------------------------------------------------- |
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