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

NCT ID: NCT01053520

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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

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Healthy Female Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Sequence I

Group Type EXPERIMENTAL

ABT-263

Intervention Type 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 II

Group Type EXPERIMENTAL

ABT-263

Intervention Type DRUG

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

Sequence III

Group Type EXPERIMENTAL

ABT-263

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Site Reference ID/Investigator# 23602

Waukegan, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M11-957

Identifier Type: -

Identifier Source: org_study_id