Relative BioavailabilityPhase 1NCT02052349

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

A Phase 1 study testing ABT-333 in people with Relative Bioavailability, run by AbbVie at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Relative Bioavailability
What is being tested?: ABT-333
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2013to Dec 2013
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Participation in a clinical research study within the previous 3 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. A breath carbon monoxide reading of greater than 10 ppm at screening
Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at screening and admission)
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
Positive hepatitis A virus immunoglobulin M (HAVIgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
Donation or loss of greater than 400 mL of blood within the previous 3 months

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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
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
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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Site Reference ID/Investigator# 118435
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase I, Open-Label Study to Investigate the Regional Bioavailability of ABT-333 When Delivered to Different Sites Within the Gastrointestinal Tract in Healthy Subjects

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

Conditions: Relative Bioavailability
Being tested: ABT-333
Keywords: relative bioavailability, healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-333Drug
Dose of ABT-333

Study groups in NCT02052349
Study group	Role	What they receive
Arm 1: ABT-333	Experimental	A single centre, open-label, 4-treatment, 3-period, 4-sequence incomplete randomised, single dose crossover study in healthy subjects. Receives: Drug: ABT-333

What is being measured

The primary outcome is the main question the study is designed to answer.

ABT-333 drug concentrations
ABT-333 concentrations in blood
Measured: Day 1 until 24 hours after single dose of ABT-333 for each period

Secondary outcomes (5)

Physical Exam
To examine any change from Day-1 in the subject's physical presentation(body temperature, pulse, blood pressure).
Measured: Day-1 until 24 hours after single dose of ABT-333 for each period
Electrocardiograms (ECGs)
The measure of any change in 12 lead electrocardiogram from Day-1
Measured: Day-1 until 3 hours after single dose of ABT-333 for each period
Safety Labs
Chemistry, Hematology, Urinalysis
Measured: Day-1 until 24 hours after single dose ABT-333 for each period
Number of participants with Adverse Events
Measured: Screening until after 7 days after last dose of ABT-333
Relative bioavailability
The measure of ABT-333 in different areas of the gastrointestinal tract
Measured: Day-1 until 24 hours after single dose of ABT-333 for each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Dec 2013

First posted3 Feb 2014 (estimated)
Study startNov 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relative BioavailabilityStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02052349
Sponsor's protocol ID: M14-108
Other IDs: 2013-003161-34
Status last verified: Jan 2014
First submitted: 30 Jan 2014
Last updated: 3 Feb 2014
Results posted: No
Data monitoring committee: No