Hepatitis CPhase 1NCT00947440
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
A Phase 1 study testing ABT-072 in people with Hepatitis C, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- ABT-072
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overall healthy subjects, non-childbearing females included.
Who cannot join
- Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- Pregnant or breast-feeding female.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
- Positive screen for drugs of abuse, alcohol, or cotinine.
- Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 22384
Waukegan, Illinois, 60085
About this study
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.
Read the detailed description
A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.
- Conditions
- Hepatitis C
- Being tested
- ABT-072
- Keywords
- Phase 1, Bioavailability
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-072Drug
See arm description for more information
| Study group | Role | What they receive |
|---|---|---|
| Tablet 1 vs. Capsule | Active comparator | Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid. Receives: Drug: ABT-072 |
| Tablet 2 vs. Capsule | Active comparator | Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid. Receives: Drug: ABT-072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Measured: 4 days post each dose
Secondary outcomes (1)
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Measured: Through 14 days post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Cohen, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947440
- Sponsor's protocol ID
- M11-056
- Status last verified
- Sep 2010
- First submitted
- 24 Jul 2009
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
- ClinicalTrials.gov ID
- NCT00947440
- Acronym / sponsor ID
- M11-056
- Conditions
- Hepatitis C
- Keywords
- Phase 1, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.
Detailed description
A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet 1 vs. Capsule | Active comparator | Drug: ABT-072Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid. |
| Tablet 2 vs. Capsule | Active comparator | Drug: ABT-072Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overall healthy subjects, non-childbearing females included.
Key exclusion criteria (6 listed)
- Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- Pregnant or breast-feeding female.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
- Positive screen for drugs of abuse, alcohol, or cotinine.
- Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-072See arm description for more information | Drug | Tablet 1 vs. Capsule, Tablet 2 vs. Capsule |
Primary outcome
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Time frame: 4 days post each dose
1 secondary outcome
To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
Time frame: Through 14 days post last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cohen, MD study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-072 in people with Hepatitis C, run by Abbott at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation. (time frame: 4 days post each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2010.