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
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 April 16, 2014