HCV InfectionPhase 1NCT00768690
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
A Phase 1 study testing ABT-333 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-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 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-333 and ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 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
- See above for main selection criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 12701
Waukegan, Illinois, 60085
About this study
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 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-333
- Conditions
- HCV Infection
- Being tested
- ABT-333, 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-333Drug
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
ketoconazoleDrug
Tablet, see arms for intervention description
placeboDrug
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole Receives: Drug: ABT-333; Drug: ketoconazole; Drug: placebo |
| 2 | Other | Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID Receives: Drug: ABT-333; Drug: placebo |
| 3 | Other | Healthy volunteers, receiving 600mg ABT-333 or placebo, BID Receives: Drug: ABT-333; Drug: placebo |
| 4 | Other | Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID Receives: Drug: ABT-333; Drug: placebo |
| 5 | Other | Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID*
*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. Receives: Drug: ABT-333; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of pharmacokinetic results.
Measured: Approximately 1 week.
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: Approximately 1 week.
Secondary outcomes (1)
Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
Measured: Approximately 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768690
- Sponsor's protocol ID
- M10-687
- Status last verified
- Sep 2010
- First submitted
- 7 Oct 2008
- Last updated
- 13 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 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 Pharmacokinetics of Multiple Doses of ABT-333
- ClinicalTrials.gov ID
- NCT00768690
- Acronym / sponsor ID
- M10-687
- Conditions
- HCV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 8 Oct 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.
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 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-333
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ABT-333, Drug: ketoconazole, Drug: placeboHealthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole |
| 2 | Other | Drug: ABT-333, Drug: placeboHealthy volunteers, receiving 400 mg ABT-333 or placebo, BID |
| 3 | Other | Drug: ABT-333, Drug: placeboHealthy volunteers, receiving 600mg ABT-333 or placebo, BID |
| 4 | Other | Drug: ABT-333, Drug: placeboHealthy volunteers, receiving 1000mg ABT-333 or placebo, BID |
| 5 | Other | Drug: ABT-333, Drug: placeboHealthy volunteers, receiving 1600mg ABT-333 or placebo, BID* *After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. |
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:
- 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.
Key exclusion criteria (1 listed)
- See above for main selection criteria
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-333Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description. | Drug | 1, 2, 3, 4, 5 |
| ketoconazoleTablet, see arms for intervention description | Drug | 1 |
| placeboCapsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description. | Drug | 1, 2, 3, 4, 5 |
Primary outcome
Analysis of pharmacokinetic results.
Time frame: Approximately 1 week.
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: Approximately 1 week.
1 secondary outcome
Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
Time frame: Approximately 1 week.
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 13 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-333 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 1 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 13 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: Approximately 1 week.). 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 13 Oct 2010.