Bioavailability of ABT-450 and ABT-267 With Ritonavir

NCT02052362 | Completed Phase 1

• 2 other identifiers: M14-2292013-003685-14
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Absolute Bioavailability

Keywords

absolute bioavailability; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Absolute bioavailability

  dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose

  Day 1 until 72 hours after single dose of ABT-450/r/ABT-267

Secondary Outcomes (4)

• Safety Labs

  Day -1 until 72 hours after single dose of ABT-450/r/ABT-267

• Electrocardiograms (ECGs)

  Day-1 until 24 hours after single dose of ABT-450/r/ABT-267

• 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

Study Arms (2)

Group 1 - Regimen A

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267

Group 2 - Regimen B

EXPERIMENTAL

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

Drug: ABT-450/r/ABT-267

Interventions

ABT-450/r/ABT-267 DRUG

ABT-450, ABT-267 and ritonavir

Group 1 - Regimen A; Group 2 - Regimen B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Body mass index of 18.0 to 30.0 kg/m2
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use an adequate method of contraception
• 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

You may not qualify if:

• 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
• 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
• 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
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• 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
• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Site Reference ID/Investigator# 118615

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Armen Asatryan, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

GB (1)