HCV InfectionsPhase 1NCT00919490
A Study of Single Dose of ABT-333 in Healthy Male Adults
A Phase 1 study testing ABT-333 in people with HCV Infections, run by Abbott at 1 site in Japan.
Trial summary
The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HCV Infections
- What is being tested?
- ABT-333
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteJapan
- Study dates
- Jun 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has provided written consent.
- Subject is in general good health.
Who cannot join
- See above for main selection criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333
The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.
- Conditions
- HCV Infections
- Being tested
- ABT-333, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-333Drug
Tablet, see arms for interventional description
PlaceboDrug
Tablet, see arms for interventional description.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Single dose of 400 mg Receives: Drug: ABT-333 |
| Group 2 | Experimental | Single dose of 800 mg after safety evolution of Group I Receives: Drug: ABT-333 |
| Group 3 | Experimental | Single dose of 1200 mg after safety evolution of Group 2 Receives: Drug: ABT-333 |
| Group 4 | Experimental | Single dose of 1600 mg after safety evolution of Group 3 Receives: Drug: ABT-333 |
| Group 5 | Placebo comparator | Single dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
Measured: Daily assessment for 5 days then day 30 or more frequently as needed
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Measured: Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 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 HCV InfectionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd
- Investigators
- Yutaka Yamamura, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919490
- Sponsor's protocol ID
- M11-023
- Status last verified
- Sep 2010
- First submitted
- 28 May 2009
- Last updated
- 25 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333
- ClinicalTrials.gov ID
- NCT00919490
- Acronym / sponsor ID
- M11-023
- Conditions
- HCV Infections
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Japan Co.,Ltd
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- First posted
- 12 Jun 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 objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ABT-333Single dose of 400 mg |
| Group 2 | Experimental | Drug: ABT-333Single dose of 800 mg after safety evolution of Group I |
| Group 3 | Experimental | Drug: ABT-333Single dose of 1200 mg after safety evolution of Group 2 |
| Group 4 | Experimental | Drug: ABT-333Single dose of 1600 mg after safety evolution of Group 3 |
| Group 5 | Placebo comparator | Drug: PlaceboSingle dose of placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject has provided written consent.
- Subject is in general good health.
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-333Tablet, see arms for interventional description | Drug | Group 1, Group 2, Group 3, Group 4 |
| PlaceboTablet, see arms for interventional description. | Drug | Group 5 |
Primary outcome
To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring
Time frame: Daily assessment for 5 days then day 30 or more frequently as needed
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Time frame: Day 1-3
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 25 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.
Yutaka Yamamura 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-333 in people with HCV Infections, run by Abbott at 1 site in Japan.
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 2 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 25 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 Japan. 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. Some participants in this study may receive a placebo. 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 assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring (time frame: Daily assessment for 5 days then day 30 or more frequently as needed). 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 25 Oct 2010.