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CompletedNCT01053520Updated Nov 9, 2010

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

A Phase 1 interventional study of ABT-263 and ABT-263 in Healthy Female Subjects, sponsored by Abbott. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-09.

Sponsored by Abbott · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Female Subjects
03

In context

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Sequence I

    Drug: ABT-263

  • Experimental
    Sequence II

    Drug: ABT-263

  • Experimental
    Sequence III

    Drug: ABT-263

Interventions

  • DrugABT-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

  • DrugABT-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

  • DrugABT-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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Site Reference ID/Investigator# 23602
    Waukegan, Illinois 60085, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01053520
Lead sponsor
Abbott
Collaborators
Genentech, Inc.
First posted
Jan 21, 2010
Start date
Oct 2009
Primary completion
Dec 2009
Completion
Jan 2010
Last update
Nov 9, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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