Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
This study has been completed.
Sponsor:
Abbott
Collaborator:
Genentech
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01053520
First received: November 23, 2009
Last updated: November 8, 2010
Last verified: September 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 23, 2013