Bioavailability of ABT-450 and ABT-267 With Ritonavir

AbbVie

Status and phase: Completed; Phase 1

Conditions: Absolute Bioavailability

Treatments: Drug: ABT-450/r/ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052362

2013-003685-14 (EudraCT Number)

M14-229

Details and patient eligibility

About

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).

Full description

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Group 1 - Regimen A

Experimental group

Description:

8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267

Treatment:

Drug: ABT-450/r/ABT-267

Group 2 - Regimen B

Experimental group

Description:

8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267

Treatment:

Drug: ABT-450/r/ABT-267