HealthyPhase 1NCT00959816
A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
A Phase 1 study testing ABT-614 in people with Healthy, run by Abbott at 1 site in United States.
Trial summary
The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABT-614
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 40 years of age
Who cannot join
- History of bleeding disorders or deep vein thrombosis (DVT)
- Previous gastrointestinal (GI) surgery or chronic GI disease
- History of spinal surgery
- History of significant, chronic low back pain
- History of frequent headaches
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 22445
San Antonio, Texas, 78217
About this study
The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ABT-614
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-614Drug
Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose (Part 1) | Experimental | Not described Receives: Drug: ABT-614 |
| Multiple Dose (Part 2) | Experimental | Not described Receives: Drug: ABT-614 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
Measured: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses
ABT-614 levels in cerebral spinal fluid
Measured: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
ABT-614 levels in blood (plasma)
Measured: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 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 HealthyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959816
- Sponsor's protocol ID
- M11-954
- Status last verified
- Sep 2010
- First submitted
- 13 Aug 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 Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
- ClinicalTrials.gov ID
- NCT00959816
- Acronym / sponsor ID
- M11-954
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- First posted
- 17 Aug 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 objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose (Part 1) | Experimental | Drug: ABT-614 |
| Multiple Dose (Part 2) | Experimental | Drug: ABT-614 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects between 18 and 40 years of age
Key exclusion criteria (5 listed)
- History of bleeding disorders or deep vein thrombosis (DVT)
- Previous gastrointestinal (GI) surgery or chronic GI disease
- History of spinal surgery
- History of significant, chronic low back pain
- History of frequent headaches
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-614Single dose administered on Study Day 1 in Part 1, daily dose administered on Study Days 1-14 in Part 2. | Drug | Multiple Dose (Part 2), Single Dose (Part 1) |
Primary outcome
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
Time frame: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses
ABT-614 levels in cerebral spinal fluid
Time frame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
ABT-614 levels in blood (plasma)
Time frame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
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.
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-614 in people with Healthy, 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 1 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 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 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?
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination) (time frame: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses). 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.