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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01053520
First received: November 23, 2009
Last updated: November 8, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Healthy Female Subjects
Drug: ABT-263
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A . [ Time Frame: Each formulation assessed via 13 PK timepoints over 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics. [ Time Frame: Assessed over the confinement period of 17 days of study duration ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: ABT-263
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
Other Name: ABT-263
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
Other Name: ABt-263

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053520

Locations
United States, Illinois
Site Reference ID/Investigator# 23602
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Genentech
  More Information

No publications provided

Responsible Party: Andrew Krivoshik, MD, PhD, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01053520     History of Changes
Other Study ID Numbers: M11-957
Study First Received: November 23, 2009
Last Updated: November 8, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014