Bioavailability of ABT-450 and ABT-267 With Ritonavir

Study Overview
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Brief Summary
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A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).

Detailed Description
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Absolute bioavailability of ABT-267 and ABT-450 in the body when given together

Official Title
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A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) When Administered as an Oral Co-Formulated Product With Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects

Conditions
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Absolute Bioavailability

Intervention / Treatment
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* Drug: ABT-450/r/ABT-267


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or non-pregnant, non-lactating healthy females Body mass index of 18.0 to 30.0 kg/m2 Must be willing and able to communicate and participate in the whole study Must provide written informed consent Must agree to use an adequate method of contraception In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Regimen A<br>8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267 | Drug: ABT-450/r/ABT-267<br>* ABT-450, ABT-267 and ritonavir<br>|
| Experimental: Group 2 - Regimen B<br>8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267 | Drug: ABT-450/r/ABT-267<br>* ABT-450, ABT-267 and ritonavir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute bioavailability | dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose | Day 1 until 72 hours after single dose of ABT-450/r/ABT-267 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Labs | Chemistry, Haematology, Urinalysis | Day -1 until 72 hours after single dose of ABT-450/r/ABT-267 | 
| Electrocardiograms (ECGs) | The measure of any change in 12 lead electrocardiogram from Day-1 | Day-1 until 24 hours after single dose of ABT-450/r/ABT-267 | 
| Number of participants with adverse events |  | Screening until 7 days after single dose of ABT-450/r/ABT-267 | 
| Physical Exam | To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse) | Day-1 until 72 hours after single dose ABT-450/r/ABT-267 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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absolute bioavailability, healthy volunteers