Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Study Details
Study Description
Brief Summary
This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence I
|
Drug: ABT-263
Period 1: Single (oral) dose of 25 mg of Formulation A Period 2: Single (oral) dose of 25 mg of Formulation B1 Period 3: Single (oral) dose of 25 mg of Formulation B2
|
| Experimental: Sequence II
|
Drug: ABT-263
Period 1: Single (oral) dose of 25 mg of Formulation B1 Period 2: Single (oral) dose of 25 mg of Formulation B2 Period 3: Single (oral) dose of 25 mg of Formulation A
|
| Experimental: Sequence III
|
Drug: ABT-263
Period 1: Single (oral) dose of 25 mg of Formulation B2 Period 2: Single (oral) dose of 25 mg of Formulation A Period 3: Single (oral) dose of 25 mg of Formulation B1
|
Outcome Measures
Primary Outcome Measures
- Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A . [Each formulation assessed via 13 PK timepoints over 4 days]
Secondary Outcome Measures
- Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics. [Assessed over the confinement period of 17 days of study duration]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female and age is between 18 and 55 years, inclusive.
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Must be surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), postmenopausal (for at least 2 years), or practicing at least one acceptable method of birth control.
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Must have negative results for pregnancy tests performed at Screening on a urine sample obtained within 28 days prior to initial study drug administration, and on Period 1 Day -1 on a serum specimen.
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Body Mass Index (BMI) is 18 to 29, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.
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Must have adequate bone marrow function per local laboratory reference range (Platelets >/= lower limit of normal range, ANC >/= lower limit of normal range)
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A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
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Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study-specific procedures.
Exclusion Criteria:
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History of significant sensitivity to any drug
-
History of drug or alcohol abuse w/i 6 months or currently receiving Disulfiram
-
Known/suspected history of HIV
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History of or active medical condition(s) or surgical procedure(s) that might affect GI motility, pH, absorption
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History of thrombocytopenic associated bleeding w/i 1 year prior to ABT-263
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Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, respiratory (except mild asthma), gastrointestinal, hematologic, or hepatic disease or diabetes, cancer, epilepsy, or seizures that in the opinion of the PI would adversely affect her participating in the study.
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Underlying condition predisposing to bleeding or currently exhibits signs of clinically significant bleeding or active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
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Positive result for drugs of abuse, alcohol, cotinine, hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
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Consumed alcohol, grapefruit or starfruit product, or Seville oranges w/i 3 days prior to ABT-263
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Received aspirin, anticoagulation therapy, or any drugs or herbal supplements that affect platelet function w/i 7 days prior to/during ABT-263
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Used any medications, vitamins, or herbal supplements (except contraceptives) w/i 14 days prior to ABT-263
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Received any drug by injection or biologic agent w/i 30 days prior to ABT-263 (except parenteral hormonal contraceptives)
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Used known inhibitors or inducers CYP3A w/i 1 month prior to ABT-263; Received any investigational product w/i 6 weeks prior to ABT-263
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Used tobacco or nicotine-products w/i 6 months prior to ABT-263
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Pregnant or breastfeeding
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Donation or loss of >/=550 mL blood or received transfusion of blood product w/i 8 weeks prior ABT-263
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Currently enrolled in another study.
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The PI decides the subject is unsuitable to receive ABT-263.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 23602 | Waukegan | Illinois | United States | 60085 |
Sponsors and Collaborators
- Abbott
- Genentech, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M11-957