HealthyPhase 1NCT01462786
To Evaluate the Safety, Tolerability and to Compare the Pharmacokinetic Profile of ATX-101
A Phase 1 study testing ATX-101 in people with Healthy, run by Kythera Biopharmaceuticals at 1 site in United States.
Trial summary
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to compare the pharmacokinetic profile of ATX-101 administered into subcutaneous fat in the submental area and abdomen. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2011
- 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
- Presence of submental fat graded by the investigator as 3 or 4 using the SMF Rating Scale (Appendix C) as a guideline.
- Sufficient submental and abdominal fat such that the protocol-specified number of injections can be safely administered.
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on the date of dosing with ATX-101. 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 for the first confinement period, 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.
- A normal result on coagulation tests (PT, PTT) obtained within 28 days before subject's first dosing session.
- Serum hemoglobin test result of 12.0 g/dL or greater and negative hepatitis B, hepatitis C, and HIV test result within 28 days before the dose of study material.
- Ability 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
- History of any intervention to treat submental or abdominal fat (e.g., liposuction, surgery, or lipolytic agents).
- History of trauma associated with the chin, neck, or abdominal areas, which in the judgment of the investigator may affect evaluation of safety or efficacy 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 or abdominal area other than localized subcutaneous fat.
- Obesity as defined by a body mass index (BMI) > 34 at the screening visit. Refer to Appendix B.
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- Any blood donation or significant blood loss within 56 days before the dose of study material or plasma donation within 7 days before the dose of study material.
- Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), 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 fish oil, aspirin, or nonsteroidal anti-inflammatory agents (NSAIDS), except acetaminophen, within seven days before dosing, or any anticipated need for agents with anticoagulative effects (e.g., warfarin, heparin) during the course of the trial.
- Treatment with oral anticoagulants (e.g., warfarin) within 30 days before dosing with study material.
- Expected to require treatment with any systemic medication during the study period (excluding any protocol-specified treatments)
- Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session.
- History of sensitivity to any components of the study material or to topical anesthetics (e.g., lidocaine, benzocaine, novocaine).
- History of drug or alcohol abuse, in the judgment of the investigator, within two years before the dose of study material.
- Presence of a 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 the dose of study material.
- Previous enrollment into a trial of ATX-101.
- Treatment with an investigational agent within 30 days before dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Crossover, Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental and Abdominal Areas
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to compare the pharmacokinetic profile of ATX-101 administered into subcutaneous fat in the submental area and abdomen.
- Conditions
- Healthy
- Being tested
- ATX-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101Drug
2 mg/cm2 ATX-101
| Study group | Role | What they receive |
|---|---|---|
| ATX-101 in abdomen area | Experimental | Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session Receives: Drug: ATX-101 |
| ATX-101 in submental area | Experimental | Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session Receives: Drug: ATX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ATX-101 injections as assessed by incidence, severity and duration of AEs of ATX-101 administered into subcutaneous fat in the submental and abdomen area
This is a single center, open-label, crossover study in which subjects will receive 2 mg/cm2 ATX-101 as indicated below in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session. For the first dosing session dosing will occur on Day 0 with the 2nd dosing session occurring on Day 8. A final follow-up visit will occur on Day 14.
Measured: 2 weeks
Secondary outcomes (1)
To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental and abdomen area
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionDec 2011
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Walker, MD, PhD, Study director, Kythera Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462786
- Sponsor's protocol ID
- ATX-101-11-30
- Status last verified
- May 2016
- First submitted
- 17 Oct 2011
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Crossover, Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental and Abdominal Areas
- ClinicalTrials.gov ID
- NCT01462786
- Acronym / sponsor ID
- ATX-101-11-30
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Oct 2011 (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 trial are to evaluate the safety and tolerability of ATX-101 injections and to compare the pharmacokinetic profile of ATX-101 administered into subcutaneous fat in the submental area and abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATX-101 in abdomen area | Experimental | Drug: ATX-101Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session |
| ATX-101 in submental area | Experimental | Drug: ATX-101Crossover study in which subjects will receive 2 mg/cm2 ATX-101 in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presence of submental fat graded by the investigator as 3 or 4 using the SMF Rating Scale (Appendix C) as a guideline.
- Sufficient submental and abdominal fat such that the protocol-specified number of injections can be safely administered.
- Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on the date of dosing with ATX-101. 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 for the first confinement period, 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.
- A normal result on coagulation tests (PT, PTT) obtained within 28 days before subject's first dosing session.
- Serum hemoglobin test result of 12.0 g/dL or greater and negative hepatitis B, hepatitis C, and HIV test result within 28 days before the dose of study material.
Key exclusion criteria (17 listed)
- History of any intervention to treat submental or abdominal fat (e.g., liposuction, surgery, or lipolytic agents).
- History of trauma associated with the chin, neck, or abdominal areas, which in the judgment of the investigator may affect evaluation of safety or efficacy 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 or abdominal area other than localized subcutaneous fat.
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-1012 mg/cm2 ATX-101 | Drug | ATX-101 in abdomen area, ATX-101 in submental area |
Primary outcome
Safety of ATX-101 injections as assessed by incidence, severity and duration of AEs of ATX-101 administered into subcutaneous fat in the submental and abdomen area
Time frame: 2 weeks
This is a single center, open-label, crossover study in which subjects will receive 2 mg/cm2 ATX-101 as indicated below in one dosing session in either the submental area or the abdomen crossing over to the alternate area for the second dosing session. For the first dosing session dosing will occur on Day 0 with the 2nd dosing session occurring on Day 8. A final follow-up visit will occur on Day 14.
1 secondary outcome
To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental and abdomen area
Time frame: 2 weeks
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 6 May 2016.
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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.
Patricia Walker, MD, PhD study director
Kythera Biopharmaceuticals
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 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 8 inclusion and 17 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 6 May 2016. 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 of ATX-101 injections as assessed by incidence, severity and duration of AEs of ATX-101 administered into subcutaneous fat in the submental and abdomen area (time frame: 2 weeks). 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 6 May 2016.