Hepatitis CPhase 1NCT00752687
A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
A Phase 1 study testing ABT-072 in people with Hepatitis C, run by Abbott at 1 site in United States.
Trial summary
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Criteria for Healthy Adults:
- Informed consent has been obtained
- Subject is in general good health
- If female, then postmenopausal
- If female, then not pregnant
- If male, must be surgically sterile or both he and the partner must use birth control
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- Body Mass Index is 18 to 29, inclusive
- Criteria for HCV-infected Adults:
- Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
- Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL
Who cannot join
- Criteria for Healthy Adults:
- If female, then pregnant or breast feeding
- Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
- Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
- Alcohol intake within 48 hours prior to study drug administration
- Criteria for HCV-infected Adults:
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- Need for prescription or over-the-counter medication
- Child Pugh score > 5 or clinical evidence of cirrhosis
- No other cause for liver disease other than HCV infection
- ALT or AST > 4 x ULN
- Creatinine > ULN
- Clinically significant abnormal ECG
- HCV RNA levels above the level of assay quantification
- TSH values outside normal range
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information
Abbott Park, Illinois, 60064
About this study
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.
Read the detailed description
A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.
- Conditions
- Hepatitis C
- Being tested
- ABT-072, placebo
- Keywords
- Phase 1
- 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
Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
placeboDrug
Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Single dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers Receives: Drug: ABT-072; Drug: placebo |
| 2 | Other | HCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD Receives: Drug: ABT-072; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Measured: 2 weeks
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752687
- Sponsor's protocol ID
- M10-573
- Status last verified
- Sep 2010
- First submitted
- 12 Sep 2008
- Last updated
- 21 Oct 2010
- Results posted
- 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
- A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
- ClinicalTrials.gov ID
- NCT00752687
- Acronym / sponsor ID
- M10-573
- Conditions
- Hepatitis C
- Keywords
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- First posted
- 15 Sep 2008 (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.
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.
Detailed description
A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ABT-072, Drug: placeboSingle dose of ABT-072, dose escalation ranging from 10 mg to 320 mg or placebo in healthy volunteers |
| 2 | Other | Drug: ABT-072, Drug: placeboHCV positive subjects administered 160mg ABT-072 or placebo, multi-dose, QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent has been obtained
- Subject is in general good health
- If female, then postmenopausal
- If female, then not pregnant
- If male, must be surgically sterile or both he and the partner must use birth control
Key exclusion criteria (14 listed)
- If female, then pregnant or breast feeding
- Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
- Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
- Alcohol intake within 48 hours prior to study drug administration
- Need for prescription or over-the-counter medication
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-072Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description. | Drug | 1, 2 |
| placeboCapsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description. | Drug | 1, 2 |
Primary outcome
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
Time frame: 2 weeks
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time frame: 2 weeks
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 10 inclusion and 14 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?
Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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.