HealthyPhase 1NCT01050127
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
A Phase 1 study testing ABT-436 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, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABT-436
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age is between 18 and 55 years, inclusive.
- If female, subject must be postmenopausal for at least two years or surgically sterile.
- Females must have negative results for pregnancy tests prior to study drug administration.
- If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
- Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
- A condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram.
- Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of significant sensitivity or allergy to any drug.
- Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
- Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
- Receipt of any depot drug by injection within 30 days prior to study drug administration.
- Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
- Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
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- Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
- Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.
- Has a clinically significant abnormal diastolic blood pressure (< 45 or > 90 mm Hg), systolic blood pressure (< 85 or > 140 mm Hg) or heart rate (< 45 or > 100 bpm).
- HbA1c > 6.0%.
Trial locations and contacts
1 site in 1 country.
United States1 site
Site Reference ID/Investigator# 24849
Waukegan, Illinois, 60085
About this study
The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.
- Conditions
- Healthy
- Being tested
- ABT-436, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Drug Safety, Phase 1 Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-436Drug
See Arm Description for details.
PlaceboDrug
See Arm Description for details.
| Study group | Role | What they receive |
|---|---|---|
| Low dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 7 days. Receives: Drug: ABT-436; Drug: Placebo |
| Mid Dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 7 days. Receives: Drug: ABT-436; Drug: Placebo |
| High Dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 14 days. Receives: Drug: ABT-436; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
Measured: Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
Measured: Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
Measured: Day -1 through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050127
- Sponsor's protocol ID
- M11-731
- Status last verified
- Sep 2010
- First submitted
- 4 Dec 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 Multiple Doses of ABT-436 in Healthy Adults
- ClinicalTrials.gov ID
- NCT01050127
- Acronym / sponsor ID
- M11-731
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Pharmacodynamics, Drug Safety, Phase 1 Clinical Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 15 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.
The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose ABT-436 | Experimental | Drug: ABT-436, Drug: PlaceboABT-436 or placebo administered once daily for 7 days. |
| Mid Dose ABT-436 | Experimental | Drug: ABT-436, Drug: PlaceboABT-436 or placebo administered once daily for 7 days. |
| High Dose ABT-436 | Experimental | Drug: ABT-436, Drug: PlaceboABT-436 or placebo administered once daily for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age is between 18 and 55 years, inclusive.
- If female, subject must be postmenopausal for at least two years or surgically sterile.
- Females must have negative results for pregnancy tests prior to study drug administration.
- If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
- Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
Key exclusion criteria (10 listed)
- History of significant sensitivity or allergy to any drug.
- Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
- Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
- Receipt of any depot drug by injection within 30 days prior to study drug administration.
- Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
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-436See Arm Description for details. | Drug | High Dose ABT-436, Low dose ABT-436, Mid Dose ABT-436 |
| PlaceboSee Arm Description for details. | Drug | High Dose ABT-436, Low dose ABT-436, Mid Dose ABT-436 |
Primary outcome
Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
Time frame: Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
Time frame: Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
Time frame: Day -1 through Day 7
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.
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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-436 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 7 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. 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., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations) (time frame: Days -2 through Day 7 or 14). 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 3 Nov 2010.