SchizophreniaPhase 1NCT01043458
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
A Phase 1 study testing ABT-126 in people with Schizophrenia, run by Abbott at 2 sites in United States.
Trial summary
A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ABT-126
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Jan 2010
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subject has signed informed consent;
- Current diagnosis of schizophrenia;
- Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
- Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
- Females are not pregnant, not breast-feeding;
- Females are post-menopausal or surgically sterile or practicing birth control;
- Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
Who cannot join
- Diagnosis of schizoaffective disorder;
- Diagnosis with mental retardation;
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Acute psychosis hospitalization within past 6 months;
- Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
- Current clozapine treatment;
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- Suicidal ideation or behavior;
- BMI of 39 or greater;
- Relevant drug sensitivity or allergy;
- Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
- Recent clinically significant illness/infection or surgery;
- Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site Reference ID/Investigator# 25423
Glendale, California, 91206
Site Reference ID/Investigator# 24322
San Antonio, Texas, 78217
About this study
Official title: A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
- Conditions
- Schizophrenia
- Being tested
- ABT-126, Placebo for ABT-126
- Keywords
- Pharmacokinetics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-126Drug
ABT-126 Low Dose \& ABT-126 High Dose
Placebo for ABT-126Drug
Matching Placebo for Arms 1 \& 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ABT-126 Low Dose Receives: Drug: ABT-126 |
| 2 | Experimental | ABT-126 High Dose Receives: Drug: ABT-126 |
| 3 | Experimental | Placebo for ABT-126 Receives: Drug: Placebo for ABT-126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Duration of study
ABT-126 levels in blood (plasma)
Measured: Pre-dose to 144 hours post-dose
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Measured: Pre-dose to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043458
- Sponsor's protocol ID
- M11-108
- Status last verified
- Sep 2010
- First submitted
- 21 Oct 2009
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT01043458
- Acronym / sponsor ID
- M11-108
- Conditions
- Schizophrenia
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- First posted
- 6 Jan 2010 (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.
A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-126ABT-126 Low Dose |
| 2 | Experimental | Drug: ABT-126ABT-126 High Dose |
| 3 | Experimental | Drug: Placebo for ABT-126Placebo for ABT-126 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject has signed informed consent;
- Current diagnosis of schizophrenia;
- Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
- Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
- Females are not pregnant, not breast-feeding;
Key exclusion criteria (12 listed)
- Diagnosis of schizoaffective disorder;
- Diagnosis with mental retardation;
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Acute psychosis hospitalization within past 6 months;
- Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive 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-126ABT-126 Low Dose \& ABT-126 High Dose | Drug | 1, 2 |
| Placebo for ABT-126Matching Placebo for Arms 1 \& 2 | Drug | 3 |
Primary outcome
Adverse Events
Time frame: Duration of study
ABT-126 levels in blood (plasma)
Time frame: Pre-dose to 144 hours post-dose
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Time frame: Pre-dose to 72 hours post-dose
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 2 Nov 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.
2 sites 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-126 in people with Schizophrenia, run by Abbott at 2 sites 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 7 inclusion and 12 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 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adverse Events (time frame: Duration of study). The study lists 3 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 2 Nov 2010.