Absolute Bioavailability
Conditions
Keywords
absolute bioavailability, healthy volunteers
Brief summary
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
Absolute bioavailability of ABT-267 and ABT-450 in the body when given together
Interventions
ABT-450, ABT-267 and ritonavir
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males or non-pregnant, non-lactating healthy females 2. Body mass index of 18.0 to 30.0 kg/m2 3. Must be willing and able to communicate and participate in the whole study 4. Must provide written informed consent 5. Must agree to use an adequate method of contraception 6. 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
1. 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 2. 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 3. 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 4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results 5. 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 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute bioavailability | Day 1 until 72 hours after single dose of ABT-450/r/ABT-267 | dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Labs | Day -1 until 72 hours after single dose of ABT-450/r/ABT-267 | Chemistry, Haematology, Urinalysis |
| Electrocardiograms (ECGs) | Day-1 until 24 hours after single dose of ABT-450/r/ABT-267 | The measure of any change in 12 lead electrocardiogram from Day-1 |
| Number of participants with adverse events | Screening until 7 days after single dose of ABT-450/r/ABT-267 | — |
| Physical Exam | Day-1 until 72 hours after single dose ABT-450/r/ABT-267 | To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse) |
Countries
United Kingdom
Outcome results
None listed