HealthyPhase 1ATX-101-11-24NCT01706679
Evaluation of the Effect of ATX-101 on QT/QTc Intervals
A Phase 1 study testing ATX-101 (10 mg/ml), ATX-101 (20 mg/ml) and Moxifloxacin (400 mg) in people with Healthy, run by Kythera Biopharmaceuticals at 1 site in United States.
Trial summary
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ATX-101 (10 mg/ml), ATX-101 (20 mg/ml) and Moxifloxacin (400 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years (inclusive). Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period and after admission to the research facility, but before the dose of study material. Females of postmenopausal status must not have had menses for at least one year and if younger than 55 years of age must have a serum FSH level ≥ 35 mIU/mL. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
- Body Mass Index (BMI) in the range of 20 - 38 kg/m2 (inclusive). Refer to Appendix A.
- Presence of sufficient submental fat into which 25 subcutaneous injections spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
- Normal vital signs after 10 minutes resting in a supine position:
- Systolic Blood Pressure: 90 mm Hg to 140 mm Hg
- Diastolic Blood Pressure: 45 mm Hg to 90 mm Hg
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- Heart Rate: 45 bpm to 100 bpm
- Normal Resting ECG
- PR Interval: 120 msec to 220 msec
- QRS Duration: < 120 msec
- QTcF Duration: < 450 msec
- Serum hemoglobin test result of 11.0 g/dL or greater and negative hepatitis B, hepatitis C, and HIV test result within 28 days before the dose of study material.
- Willing and able to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
- Medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before dosing with study material for which the investigator identifies no clinically significant abnormality.
- Signed informed consent obtained before any study-specific procedure is conducted.
Who cannot join
- Any prescription medication taken within 14 days (or 5 elimination half-lives, whichever is longer) of Study Day -2, or have taken any over-the-counter medications, including topical medications, herbal or dietary supplements/remedies within 7 days of Study Day 2, or planned concomitant medication while in the study (except for acetaminophen up to 2 g/day and hormonal birth control).
- A history of additional risk factors for Torsade de Pointes (e.g. hypokalemia, history of drowning survival, family history of Long QT Syndrome, family history of Short QT Syndrome, or family history of unexplainable early sudden death).
- Participation in a study of an investigational drug or device within 30 days prior to the baseline ECG.
- Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.
- Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute.
- Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity.
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- Subjects not in sinus rhythm at screening.
- Hypersensitivity to Moxifloxacin
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- Use of tobacco or nicotine-containing products within 3 months prior to dose.
- History of any intervention to treat submental fat (e.g. liposuction, surgery, or lipolytic agents).
- History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety of treatment.
- Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in a cosmetically unacceptable outcome.
- Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
- Any blood donation or significant blood loss within 56 days before the dose of study material or plasma donation within 7 days of Day -1.
- A result on coagulation tests (PT, PTT) obtained within 28 days before the dose of study material that indicates the presence of any clinically significant bleeding disorder.
- Any medical condition that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
- Treatment with oral anticoagulants (e.g. warfarin) within 30 days before dosing with study material.
- Treatment with radio frequency, laser procedure, chemical peels, or dermal fillers in the neck or chin within 12 months before dosing with the study material, or botulinum toxin injections in the neck or chin area within 6 months before dosing with the study material.
- History of sensitivity to any components of the study material.
- History of drug or alcohol abuse, in the judgment of the investigator, within two years before dosing with the study material.
- Presence of positive urine drug or alcohol screening test result obtained from a sample obtained during the screening period and/or after admission to the research facility for the confinement period, but before dosing with the study material.
- Previous enrollment in a trial of ATX-101.
- Treatment with an investigational device or agent within 30 days prior to the baseline ECG.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development
Miramar, Florida, 33027
About this study
Official title: A Four-Arm, Parallel Design, Randomized, Double-Blinded, Placebo and Active Controlled Study for the Evaluation of the Effect of Maximum Therapeutic and Supratherapeutic Single-Dose ATX-101 on the QT/QTc Intervals in Healthy Volunteers
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
- Conditions
- Healthy
- Being tested
- ATX-101 (10 mg/ml), ATX-101 (20 mg/ml), Moxifloxacin (400 mg), Placebo vehicle (PBS)
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101 (10 mg/ml)Drug
ATX-101 (20 mg/ml)Drug
Moxifloxacin (400 mg)Drug
Placebo vehicle (PBS)Drug
| Study group | Role | What they receive |
|---|---|---|
| Maximum therapeutic dose of ATX-101 | Active comparator | ATX-101 10 mg/ml Receives: Drug: ATX-101 (10 mg/ml) |
| Supratherapeutic dose of ATX-101 | Active comparator | ATX-101 20 mg/ml Receives: Drug: ATX-101 (20 mg/ml) |
| Moxifloxacin | Active comparator | moxifloxacin (400mg) Receives: Drug: Moxifloxacin (400 mg) |
| Placebo vehicle | Placebo comparator | placebo vehicle (PBS) Receives: Drug: Placebo vehicle (PBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF)
The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec.
Measured: 2.5 days
Secondary outcomes (1)
To evaluate change from placebo and baseline of the maximum therapeutic and supratherapeutic doses of ATX-101 treatment on QT interval corrected for individuals
Measured: 2.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionJun 2013
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
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Royce Morrison, MD, PhD, Principal investigator, Comprehensive Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706679
- Sponsor's protocol ID
- ATX-101-11-24
- Acronym
- ATX-101-11-24
- Status last verified
- Oct 2012
- First submitted
- 11 Oct 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Arm, Parallel Design, Randomized, Double-Blinded, Placebo and Active Controlled Study for the Evaluation of the Effect of Maximum Therapeutic and Supratherapeutic Single-Dose ATX-101 on the QT/QTc Intervals in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01706679
- Acronym / sponsor ID
- ATX-101-11-24 / ATX-101-11-24
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Oct 2012 (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.
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maximum therapeutic dose of ATX-101 | Active comparator | Drug: ATX-101 (10 mg/ml)ATX-101 10 mg/ml |
| Supratherapeutic dose of ATX-101 | Active comparator | Drug: ATX-101 (20 mg/ml)ATX-101 20 mg/ml |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin (400 mg)moxifloxacin (400mg) |
| Placebo vehicle | Placebo comparator | Drug: Placebo vehicle (PBS)placebo vehicle (PBS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years (inclusive). Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period and after admission to the research facility, but before the dose of study material. Females of postmenopausal status must not have had menses for at least one year and if younger than 55 years of age must have a serum FSH level ≥ 35 mIU/mL. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
- Body Mass Index (BMI) in the range of 20 - 38 kg/m2 (inclusive). Refer to Appendix A.
- Presence of sufficient submental fat into which 25 subcutaneous injections spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
- Normal vital signs after 10 minutes resting in a supine position:
- Normal Resting ECG
Key exclusion criteria (25 listed)
- Any prescription medication taken within 14 days (or 5 elimination half-lives, whichever is longer) of Study Day -2, or have taken any over-the-counter medications, including topical medications, herbal or dietary supplements/remedies within 7 days of Study Day 2, or planned concomitant medication while in the study (except for acetaminophen up to 2 g/day and hormonal birth control).
- A history of additional risk factors for Torsade de Pointes (e.g. hypokalemia, history of drowning survival, family history of Long QT Syndrome, family history of Short QT Syndrome, or family history of unexplainable early sudden death).
- Participation in a study of an investigational drug or device within 30 days prior to the baseline ECG.
- Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.
- Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute.
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 |
|---|---|---|
| ATX-101 (10 mg/ml) | Drug | Maximum therapeutic dose of ATX-101 |
| ATX-101 (20 mg/ml) | Drug | Supratherapeutic dose of ATX-101 |
| Moxifloxacin (400 mg) | Drug | Moxifloxacin |
| Placebo vehicle (PBS) | Drug | Placebo vehicle |
Primary outcome
The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF)
Time frame: 2.5 days
The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec.
1 secondary outcome
To evaluate change from placebo and baseline of the maximum therapeutic and supratherapeutic doses of ATX-101 treatment on QT interval corrected for individuals
Time frame: 2.5 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 14 Nov 2013.
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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.
Royce Morrison, MD, PhD principal investigator
Comprehensive Clinical Development
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 ATX-101 (10 mg/ml), ATX-101 (20 mg/ml) and Moxifloxacin (400 mg) in people with Healthy, run by Kythera Biopharmaceuticals 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 15 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 14 Nov 2013. 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?
The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF) (time frame: 2.5 days). 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 14 Nov 2013.