A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1, Bioequivalence Sequence Group 1 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. |
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
Drug: Veliparib, tablet
tablet; 400 mg
Other Names:
|
Experimental: Part 2, Extension Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion. |
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
Drug: Carboplatin
Intravenous
Other Names:
Drug: Paclitaxel
Intravenous
Other Names:
|
Experimental: Part 1, Bioequivalence Sequence Group 2 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. |
Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
Drug: Veliparib, tablet
tablet; 400 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) [Up to approximately 8 days after initial dose of study drug]
Maximum observed plasma concentration (Cmax)
- Time to Maximum Observed Plasma Concentration (Tmax) [Up to approximately 8 days after initial dose of study drug]
Time to maximum observed plasma concentration (Tmax).
- Apparent Terminal Phase Elimination Rate Constant (β or Beta) [Up to approximately 8 days after initial dose of study drug]
Apparent terminal phase elimination rate constant (β or Beta).
- Terminal Phase Elimination Half-life (t1/2) [Up to approximately 8 days after initial dose of study drug]
Terminal phase elimination half-life (t1/2)
- 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]
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
- AUC from time 0 to infinite time (AUC∞) [Up to approximately 8 days after initial dose of study drug]
AUC from time 0 to infinite time (AUC∞)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
-
Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
-
Life expectancy of 12 weeks or greater.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
-
Able to swallow and retain oral medication.
-
Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
-
Non-childbearing potential.
Exclusion Criteria:
-
History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
-
Evidence of refractory ascites.
-
Has clinically relevant or significant electrocardiogram abnormalities.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M15-536
- 2018-000313-20