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

NCT ID: NCT02052349

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2013-12-31

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

Conditions

Relative Bioavailability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arm 1: ABT-333

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

Group Type: EXPERIMENTAL

ABT-333

Intervention Type: DRUG

Dose of ABT-333

Interventions

ABT-333

Dose of ABT-333

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Cohen, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 118435

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2013-003161-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-108

Identifier Type: -

Identifier Source: org_study_id