NCT02052349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

January 30, 2014

Last Update Submit

January 30, 2014

Conditions

Relative Bioavailability

Keywords

relative bioavailabilityhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • ABT-333 drug concentrations

    ABT-333 concentrations in blood

    Day 1 until 24 hours after single dose of ABT-333 for each period

Secondary Outcomes (5)

  • Physical Exam

    Day-1 until 24 hours after single dose of ABT-333 for each period

  • Electrocardiograms (ECGs)

    Day-1 until 3 hours after single dose of ABT-333 for each period

  • Safety Labs

    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

    Day-1 until 24 hours after single dose of ABT-333 for each period

Study Arms (1)

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.

Drug: ABT-333

Interventions

ABT-333DRUG

Dose of ABT-333

Arm 1: ABT-333

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 118435

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

dasabuvir

Study Officials

  • Dan Cohen, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

GB(1)