HealthyPhase 1NCT00968422
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
A Phase 1 study testing ABT-384 in people with Healthy, run by Abbott at 1 site in United States.
Trial summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABT-384
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age is 65 years or greater
- Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Who cannot join
- Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
- Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
- Receipt of any drug depot by injection within 30 days prior to study drug administration.
- Receipt of any investigational product within 6 weeks prior to study drug administration.
- History of significant sensitivity or allergy to any drug.
- History of drug or alcohol abuse within 2 years.
Show all 10Show fewer
- Positive test result for HBV, HCV or HIV.
- Estimated creatinine clearance < 30 mL/min.
- Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration.
- Current enrollment in another clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 23024
Orlando, Florida, 32809
About this study
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
- Conditions
- Healthy
- Being tested
- ABT-384, Matching placebo to ABT-384
- Keywords
- Pharmacology, Drug Safety, Phase 1 Clinical Trials, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-384Drug
3 escalating doses will be administered daily for 21 days
Matching placebo to ABT-384Drug
Doses will be administered daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Low dose ABT-384 | Experimental | Not described Receives: Drug: ABT-384 |
| Mid dose ABT-384 | Experimental | Not described Receives: Drug: ABT-384 |
| High dose ABT-384 | Experimental | Not described Receives: Drug: ABT-384 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo to ABT-384 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Measured: Days -2 through 84
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
Measured: Days -1 through 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968422
- Sponsor's protocol ID
- M10-506
- Status last verified
- Sep 2010
- First submitted
- 28 Aug 2009
- Last updated
- 3 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00968422
- Acronym / sponsor ID
- M10-506
- Conditions
- Healthy
- Keywords
- Pharmacology, Drug Safety, Phase 1 Clinical Trials, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- First posted
- 31 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 objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose ABT-384 | Experimental | Drug: ABT-384 |
| Mid dose ABT-384 | Experimental | Drug: ABT-384 |
| High dose ABT-384 | Experimental | Drug: ABT-384 |
| Placebo | Placebo comparator | Drug: Matching placebo to ABT-384 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age is 65 years or greater
- Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Key exclusion criteria (10 listed)
- Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
- Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
- Receipt of any drug depot by injection within 30 days prior to study drug administration.
- Receipt of any investigational product within 6 weeks prior to study drug administration.
- History of significant sensitivity or allergy to any drug.
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-3843 escalating doses will be administered daily for 21 days | Drug | High dose ABT-384, Low dose ABT-384, Mid dose ABT-384 |
| Matching placebo to ABT-384Doses will be administered daily for 21 days | Drug | Placebo |
Primary outcome
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time frame: Days -2 through 84
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
Time frame: Days -1 through 27
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 3 Nov 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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-384 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 2 inclusion and 10 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 3 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. 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?
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) (time frame: Days -2 through 84). 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 3 Nov 2010.