HCV InfectionPhase 1NCT00890318
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
A Phase 1 study testing ABT-072 and ketoconazole in people with HCV Infection, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HCV Infection
- What is being tested?
- ABT-072 and ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 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
- Main Selection Criteria for Healthy Volunteers:
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal for at least 2 years or surgically sterile.
- If female, subject is not pregnant and is not breast-feeding.
- Male or female between 18 and 55 years old, inclusive.
- If male, subject must be surgically sterile or practicing at least 1 method of birth control.
- Body Mass Index (BMI) is 18 to 29, inclusive.
Who cannot join
- Use of medications including over the counter and vitamines.
- Abuse of alcohol, drugs, or nicotine.
- Current diseases or disorders.
- History of cardiac disease.
- If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Clinical Pharmaceutical Research Unit
Waukegan, Illinois, 60085
About this study
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
Read the detailed description
Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072
- Conditions
- HCV Infection
- Being tested
- ABT-072, ketoconazole, Placebo
- 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
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.
ketoconazoleOther
Tablet, see Arm Description for intervention information.
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 | Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole Receives: Drug: ABT-072; Other: ketoconazole; Drug: Placebo |
| 2 | Other | Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days. Receives: Drug: ABT-072; Drug: Placebo |
| 3 | Other | Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days. 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 results.
Measured: Study Days 1-13
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: Study Days -2 through 39
Secondary outcomes (1)
Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
Measured: Study Day 11-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT00890318
- Sponsor's protocol ID
- M10-705
- Status last verified
- Sep 2010
- First submitted
- 27 Apr 2009
- 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 in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
- ClinicalTrials.gov ID
- NCT00890318
- Acronym / sponsor ID
- M10-705
- Conditions
- HCV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 29 Apr 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 determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
Detailed description
Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ABT-072, Other: ketoconazole, Drug: PlaceboHealthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole |
| 2 | Other | Drug: ABT-072, Drug: PlaceboHealthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days. |
| 3 | Other | Drug: ABT-072, Drug: PlaceboHealthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Main Selection Criteria for Healthy Volunteers:
Key exclusion criteria (5 listed)
- Use of medications including over the counter and vitamines.
- Abuse of alcohol, drugs, or nicotine.
- Current diseases or disorders.
- History of cardiac disease.
- If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
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-072Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description. | Drug | 1, 2, 3 |
| ketoconazoleTablet, see Arm Description for intervention information. | Other | 1 |
| PlaceboCapsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description. | Drug | 1, 2, 3 |
Primary outcome
Analysis of pharmacokinetic results.
Time frame: Study Days 1-13
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: Study Days -2 through 39
1 secondary outcome
Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
Time frame: Study Day 11-13
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.
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 and ketoconazole in people with HCV Infection, 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 8 inclusion and 5 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 results. (time frame: Study Days 1-13). 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.