HCV InfectionPhase 1NCT00909636
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
A Phase 1 study testing ABT-333 in people with HCV Infection, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 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
- overall healthy subjects between the ages of 18 to 55 years old;
- if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
- females must have negative results for pregnancy tests performed;
- if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:
- partner(s) using IUD,
- partner(s) using oral, injected or implanted methods of hormonal contraceptives,
- subject and/or partner(s) using double-barrier method;
- Body Mass Index is 18 to 29, inclusive
Who cannot join
- history of significant sensitivity to any drug;
- positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab;
- history of gastrointestinal issues or procedures;
- history of seizures, diabetes or cancer (except basal cell carcinoma);
- 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 with the 6-month period prior to study drug administration;
Show all 25Show fewer
- donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
- clinically significant abnormal screening laboratory analyses and ECGs:
- ALT > ULN,
- AST > ULN,
- ECG with QTcF>450 msec in females and >430 msec in males,
- or ECG with 2nd or 3rd degree atrioventricular block;
- current enrollment in another clinical study;
- previous enrollment in this study;
- recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
- pregnant or breastfeeding female;
- requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
- use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
- positive screen for drugs of abuse, alcohol, or cotinine;
- receipt of any drug by injection within 30 days prior to study drug administration;
- receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
- consumption of alcohol within 48 hours prior to study drug administration;
- consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
- consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
- history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 20081
Waukegan, Illinois, 60085
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.
- Conditions
- HCV Infection
- Being tested
- ABT-333, Placebo
- Keywords
- multiple ascending doses (MAD)
- 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
See arm description for more information
PlaceboDrug
See arm description for more information
| Study group | Role | What they receive |
|---|---|---|
| 1. ABT-333 Tablet | Active comparator | Three 400mg ABT-333 Tablets, BID Receives: Drug: ABT-333 |
| 2. ABT-333 Tablet | Active comparator | Four 400mg ABT-333 Tablets, BID Receives: Drug: ABT-333 |
| 3. Placebo | Placebo comparator | Three or four placebo tablets, BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess multiple 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: 10 days
Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startMay 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 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
- NCT00909636
- Sponsor's protocol ID
- M11-031
- Status last verified
- Sep 2010
- First submitted
- 27 May 2009
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- 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 Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults
- ClinicalTrials.gov ID
- NCT00909636
- Acronym / sponsor ID
- M11-031
- Conditions
- HCV Infection
- Keywords
- multiple ascending doses (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- First posted
- 28 May 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 safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. ABT-333 Tablet | Active comparator | Drug: ABT-333Three 400mg ABT-333 Tablets, BID |
| 2. ABT-333 Tablet | Active comparator | Drug: ABT-333Four 400mg ABT-333 Tablets, BID |
| 3. Placebo | Placebo comparator | Drug: PlaceboThree or four placebo tablets, BID |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- overall healthy subjects between the ages of 18 to 55 years old;
- if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
- females must have negative results for pregnancy tests performed;
- if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:
- Body Mass Index is 18 to 29, inclusive
Key exclusion criteria (25 listed)
- history of significant sensitivity to any drug;
- positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab;
- history of gastrointestinal issues or procedures;
- history of seizures, diabetes or cancer (except basal cell carcinoma);
- 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-333See arm description for more information | Drug | 1. ABT-333 Tablet, 2. ABT-333 Tablet |
| PlaceboSee arm description for more information | Drug | 3. Placebo |
Primary outcome
To assess multiple 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: 10 days
Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws.
Time frame: 10 days
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.
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-333 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 25 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. 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 multiple 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: 10 days). 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.