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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000313-20 | EudraCT Number |
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Strategic considerations
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This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Bioequivalence Sequence Group 1 | Experimental | Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions. |
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| Part 2, Extension | Experimental | Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. |
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| Part 1, Bioequivalence Sequence Group 2 | Experimental | Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib, capsule | Drug | capsule; 50 mg or 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Maximum observed plasma concentration (Cmax) | Up to approximately 8 days after initial dose of study drug |
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to maximum observed plasma concentration (Tmax). | Up to approximately 8 days after initial dose of study drug |
| Apparent Terminal Phase Elimination Rate Constant (β or Beta) | Apparent terminal phase elimination rate constant (β or Beta). | Up to approximately 8 days after initial dose of study drug |
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) | Up to approximately 8 days after initial dose of study drug |
| Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt). | Up to approximately 8 days after initial dose of study drug |
| AUC from time 0 to infinite time (AUC∞) | AUC from time 0 to infinite time (AUC∞) | Up to approximately 8 days after initial dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C521013 | veliparib |
| D002214 | Capsules |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Veliparib, tablet | Drug | tablet; 400 mg |
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| Carboplatin | Drug | Intravenous |
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| Paclitaxel | Drug | Intravenous |
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|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |