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

Phase 1

Completed

• Conditions: Relative Bioavailability
• Interventions: Drug: ABT-333

• Registration Number: NCT02052349
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Bioavailability of ABT-333 in different areas of the gut

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Study First Posted: 2014-02-03
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: ABT-333	ABT-333	A single centre, open-label, 4-treatment, 3-period, 4-sequence incomplete randomised, single dose crossover study in healthy subjects.

Primary Outcome Measures

Name	Time	Method
ABT-333 drug concentrations	Day 1 until 24 hours after single dose of ABT-333 for each period	ABT-333 concentrations in blood

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 118435; 🇬🇧 Nottingham, United Kingdom