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

Relative Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052349
• Other study ID #: M14-108
• Secondary ID: 2013-003161-34
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2014
• Last updated: January 30, 2014
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

Bioavailability of ABT-333 in different areas of the gut

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Relative Bioavailability

Intervention

Drug:
• ABT-333
Dose of ABT-333

Locations

Country	Name	City	State
United Kingdom	Site Reference ID/Investigator# 118435	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABT-333 drug concentrations	ABT-333 concentrations in blood	Day 1 until 24 hours after single dose of ABT-333 for each period	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Safety Labs	Chemistry, Hematology, Urinalysis	Day-1 until 24 hours after single dose ABT-333 for each period	Yes
Secondary	Number of participants with Adverse Events		Screening until after 7 days after last dose of ABT-333	Yes
Secondary	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	No