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Completed

NCT Number: NCT02052362

Bioavailability of ABT-450 and ABT-267 With Ritonavir

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 118615

Nottingham, NG11 6JS, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ABT-450/r/ABT-267

Drug

ABT-450, ABT-267 and ritonavir

Primary outcomes

  1. Absolute bioavailability

    Time frame: 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 outcomes

  1. Safety Labs

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

    Chemistry, Haematology, Urinalysis

  2. Electrocardiograms (ECGs)

    Time frame: 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

  3. Number of participants with adverse events

    Time frame: Screening until 7 days after single dose of ABT-450/r/ABT-267

  4. Physical Exam

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2014
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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