Bioavailability of ABT-450 and ABT-267 With Ritonavir

Phase 1

Completed

• Conditions: Absolute Bioavailability
• Interventions: Drug: ABT-450/r/ABT-267

• Registration Number: NCT02052362
• Lead Sponsor: AbbVie

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Posted: 2014-02-03
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Regimen A	ABT-450/r/ABT-267	8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267
Group 2 - Regimen B	ABT-450/r/ABT-267	8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Site Reference ID/Investigator# 118615; 🇬🇧 Nottingham, United Kingdom