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

NCT01053520 | Completed Phase 1

• 1 other identifier: M11-957
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Female Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Sequence I

EXPERIMENTAL

Drug: ABT-263

Sequence II

EXPERIMENTAL

Drug: ABT-263

Sequence III

EXPERIMENTAL

Drug: ABT-263

Interventions

ABT-263 DRUG

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

Sequence I

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Site Reference ID/Investigator# 23602

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Interventions

navitoclax

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: January 21, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-09

Locations

US (1)