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

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

November 23, 2009
November 8, 2010
October 2009
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01053520 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Not Provided

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Female Subjects
  • 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
  • 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
  • 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
  • Experimental: Sequence I
    Intervention: Drug: ABT-263
  • Experimental: Sequence II
    Intervention: Drug: ABT-263
  • Experimental: Sequence III
    Intervention: Drug: ABT-263
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2010
December 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053520
M11-957
No
Andrew Krivoshik, MD, PhD, Medical Director, Abbott
Abbott
Genentech, Inc.
Not Provided
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP