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

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.

Study Overview

• Status: Completed
• Conditions: Relative Bioavailability
• Intervention / Treatment: Drug: ABT-333

Detailed Description

Bioavailability of ABT-333 in different areas of the gut

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Dose of ABT-333

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABT-333 drug concentrations	ABT-333 concentrations in blood	Day 1 until 24 hours after single dose of ABT-333 for each period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Exam	To examine any change from Day-1 in the subject's physical presentation(body temperature, pulse, blood pressure).	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	Day-1 until 3 hours after single dose of ABT-333 for each period
Safety Labs	Chemistry, Hematology, Urinalysis	Day-1 until 24 hours after single dose ABT-333 for each period
Number of participants with Adverse Events		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	Day-1 until 24 hours after single dose of ABT-333 for each period

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: healthy volunteers; relative bioavailability
• Other Study ID Numbers: M14-108; 2013-003161-34 (EudraCT Number)