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Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
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| Arm B | Experimental |
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| Arm C | Experimental |
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| Arm D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veliparib | Drug | veliparib formulation A |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the oral bioavailability of veliparib | Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax). | Up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of veliparib in patients with solid tumors | Safety and tolerability will be assessed through clinical laboratory tests, electrocardiograms (ECGs), vital signs, physical exams and adverse event assessments | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The subject is unable to swallow capsules or has nausea or vomiting.
Female subject is pregnant or breast-feeding.
Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.
Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Bhardwaj Desai, MD | Abbott | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25053388 | Result | Mostafa NM, Chiu YL, Rosen LS, Bessudo A, Kovacs X, Giranda VL. A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors. Cancer Chemother Pharmacol. 2014 Sep;74(3):583-91. doi: 10.1007/s00280-014-2529-2. Epub 2014 Jul 23. |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C521013 | veliparib |
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| veliparib | Drug | veliparib formulation B |
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| veliparib | Drug | veliparib formulation C |
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| veliparib | Drug | veliparib formulation C |
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