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CompletedNCT02052349Updated Feb 3, 2014

Bioavailability of ABT-333 Within the Gastrointestinal Tract in Healthy Subjects

A Phase 1 interventional study of ABT-333 in Relative Bioavailability, sponsored by AbbVie. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-03.

Sponsored by AbbVie · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when delivered within different sites of the gastrointestinal tract in 12 healthy subjects.

Read the detailed description

Bioavailability of ABT-333 in different areas of the gut

02

Conditions studied

  • Relative Bioavailability

Keywords

  • relative bioavailability
  • healthy volunteers
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  2. Subjects must demonstrate their ability to swallow an empty size 000 capsule
  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

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical research study within the previous 3 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. A breath carbon monoxide reading of greater than 10 ppm at screening
  3. Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at screening and admission)
  4. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic xrays and other medical exposures, exceeding 5 (micro sievert) 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
  5. Positive hepatitis A virus immunoglobulin M (HAVIgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  6. Donation or loss of greater than 400 mL of blood within the previous 3 months
  7. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy (HRT) and hormonal contraception) or herbal remedies in the 14 days before Investigational Medical Product (IMP) administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study by both the Principal Investigator (or delegate) and sponsor's medical monitor
  8. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
  9. Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Arm 1: ABT-333

    A single centre, open-label, 4-treatment, 3-period, 4-sequence incomplete randomised, single dose crossover study in healthy subjects.

    Drug: ABT-333

Interventions

  • DrugABT-333

    Dose of ABT-333

06

What researchers measure

Primary outcomes

  1. ABT-333 drug concentrations

    ABT-333 concentrations in blood

    Time frame: Day 1 until 24 hours after single dose of ABT-333 for each period

Secondary outcomes

  1. Physical Exam

    To examine any change from Day-1 in the subject's physical presentation(body temperature, pulse, blood pressure).

    Time frame: Day-1 until 24 hours after single dose of ABT-333 for each period

  2. Electrocardiograms (ECGs)

    The measure of any change in 12 lead electrocardiogram from Day-1

    Time frame: Day-1 until 3 hours after single dose of ABT-333 for each period

  3. Safety Labs

    Chemistry, Hematology, Urinalysis

    Time frame: Day-1 until 24 hours after single dose ABT-333 for each period

  4. Number of participants with Adverse Events

    Time frame: Screening until after 7 days after last dose of ABT-333

  5. Relative bioavailability

    The measure of ABT-333 in different areas of the gastrointestinal tract

    Time frame: Day-1 until 24 hours after single dose of ABT-333 for each period

07

Study locations

1 site
  • Site Reference ID/Investigator# 118435
    Nottingham, NG11 6JS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02052349
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Feb 3, 2014
Start date
Nov 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Feb 3, 2014

Study contacts

Dan Cohen, MD
study director · AbbVie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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