Healthy Female Subjects
Conditions
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.
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.
Interventions
DRUGABT-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
Sponsors
Genentech, Inc.
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and age is between 18 and 55 years, inclusive. * 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. * 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. * 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. * Must have adequate bone marrow function per local laboratory reference range (Platelets \>/= lower limit of normal range, ANC \>/= lower limit of normal range) * 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). * 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
* 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 * History of or active medical condition(s) or surgical procedure(s) that might affect GI motility, pH, absorption * History of thrombocytopenic associated bleeding w/i 1 year prior to ABT-263 * 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. * Underlying condition predisposing to bleeding or currently exhibits signs of clinically significant bleeding or active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. * 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). * Consumed alcohol, grapefruit or starfruit product, or Seville oranges w/i 3 days prior to ABT-263 * Received aspirin, anticoagulation therapy, or any drugs or herbal supplements that affect platelet function w/i 7 days prior to/during ABT-263 * Used any medications, vitamins, or herbal supplements (except contraceptives) w/i 14 days prior to ABT-263 * Received any drug by injection or biologic agent w/i 30 days prior to ABT-263 (except parenteral hormonal contraceptives) * 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 * Used tobacco or nicotine-products w/i 6 months prior to ABT-263 * Pregnant or breastfeeding * Donation or loss of \>/=550 mL blood or received transfusion of blood product w/i 8 weeks prior ABT-263 * Currently enrolled in another study. * The PI decides the subject is unsuitable to receive ABT-263.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed