Clinical trial NCT02052362: Bioavailability of ABT-450 and ABT-267 With Ritonavir
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Absolute Bioavailability
Keywords: absolute bioavailability
healthy volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: Absolute bioavailability
timeFrame: Day 1 until 72 hours after single dose of ABT-450/r/ABT-267
Secondary outcomes:
measure: Safety Labs
timeFrame: Day -1 until 72 hours after single dose of ABT-450/r/ABT-267
measure: Electrocardiograms (ECGs)
timeFrame: Day-1 until 24 hours after single dose of ABT-450/r/ABT-267
measure: Number of participants with adverse events
timeFrame: Screening until 7 days after single dose of ABT-450/r/ABT-267
measure: Physical Exam
timeFrame: Day-1 until 72 hours after single dose ABT-450/r/ABT-267
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Site Reference ID/Investigator# 118615
Study officials:
affiliation: AbbVie
name: Armen Asatryan, MD
role: STUDY_DIRECTOR
References: