Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects

Abbott

Status and phase

Completed

Phase 1

Conditions

Healthy Female Subjects

Treatments

Drug: ABT-263

Study type

Interventional

Funder types

Industry

Identifiers

NCT01053520

M11-957

Details and patient eligibility

About

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.

Full description

Enrollment

12 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.