Bioavailability of ABT-450 and ABT-267 With Ritonavir

NCT ID: NCT02052362

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-02-28

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

Conditions

Absolute Bioavailability

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Group 1 - Regimen A

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

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type: DRUG

ABT-450, ABT-267 and ritonavir

Group 2 - Regimen B

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

Group Type: EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type: DRUG

ABT-450, ABT-267 and ritonavir

Interventions

ABT-450/r/ABT-267

ABT-450, ABT-267 and ritonavir

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armen Asatryan, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 118615

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2013-003685-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-229

Identifier Type: -

Identifier Source: org_study_id