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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 23, 2009
Last Updated Date	November 8, 2010
Start Date ^ICMJE	October 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01053520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Official Title ^ICMJE	Not Provided
Brief 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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy Female Subjects
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Sequence I Intervention: Drug: ABT-263 Experimental: Sequence II Intervention: Drug: ABT-263 Experimental: Sequence III Intervention: Drug: ABT-263
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	12
Completion Date	January 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01053520
Other Study ID Numbers ^ICMJE	M11-957
Has Data Monitoring Committee	No
Responsible Party	Andrew Krivoshik, MD, PhD, Medical Director, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Genentech
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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