HealthyPhase 1NCT01632917
Open-Label Pharmacokinetic Study of Final Formulations of ATX-101
A Phase 1 study testing ATX-101 - U.S. and ATX-101 - EU 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 characterize the pharmacokinetic profile of the two ATX-101 formulations. 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 - U.S. and ATX-101 - EU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2012
- 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 sufficient submental fat into which 50 subcutaneous injections of ATX-101 spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
- 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, 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.
- 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
- 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.
- Body mass index (BMI) > 40.0 at the screening visit. Refer to Appendix B.
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- Use of tobacco or nicotine-containing products within 3 months prior to dose.
- 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.
- 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 fish oil, aspirin, or nonsteroidal anti-inflammatory agents (NSAIDS), except acetaminophen, within 7 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.
- Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area 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 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 dosing with the study material.
- Previous enrollment into a trial of ATX-101.
- Treatment with an investigational device or agent within 30 days before dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development
Miramar, Florida, 33027
About this study
Official title: Phase 1, Open-Label, Randomized, Safety and Pharmacokinetic Study of Two Final Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental Fat
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.
Read the detailed description
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations that are expected to be the final formulations. ATX-101 will be administered into the submental fat as subcutaneous injections using the maximum proposed dosing regimen that is intended for labeling.
- Conditions
- Healthy
- Being tested
- ATX-101 - U.S., ATX-101 - EU
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101 - U.S.Drug
US ATX-101, 10 mg/mL, one dosing session in the submental area
ATX-101 - EUDrug
EU ATX-101, 10 mg/mL, one dosing session in the submental area
| Study group | Role | What they receive |
|---|---|---|
| ATX-101 - EU | Experimental | Open Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area Receives: Drug: ATX-101 - EU |
| ATX-101 - US | Experimental | Open Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area Receives: Drug: ATX-101 - U.S. |
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
Spontaneously reported adverse events, laboratory test results, and treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphagia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus.
Measured: 8 days
Secondary outcomes (1)
To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental area
Blood sampling at specified time points before and after dosing with ATX-101 for analysis of deoxycholate concentrations in the plasma.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
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
- None (open label)
- Enrolment
- 24 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, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632917
- Sponsor's protocol ID
- ATX-101-12-32
- Status last verified
- Sep 2012
- First submitted
- 29 Jun 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Safety and Pharmacokinetic Study of Two Final Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental Fat
- ClinicalTrials.gov ID
- NCT01632917
- Acronym / sponsor ID
- ATX-101-12-32
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Jul 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.
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.
Detailed description
The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations that are expected to be the final formulations. ATX-101 will be administered into the submental fat as subcutaneous injections using the maximum proposed dosing regimen that is intended for labeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATX-101 - EU | Experimental | Drug: ATX-101 - EUOpen Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area |
| ATX-101 - US | Experimental | Drug: ATX-101 - U.S.Open Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of sufficient submental fat into which 50 subcutaneous injections of ATX-101 spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
- 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, 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.
- 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.
Key exclusion criteria (18 listed)
- 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.
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 - U.S.US ATX-101, 10 mg/mL, one dosing session in the submental area | Drug | ATX-101 - US |
| ATX-101 - EUEU ATX-101, 10 mg/mL, one dosing session in the submental area | Drug | ATX-101 - EU |
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: 8 days
Spontaneously reported adverse events, laboratory test results, and treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphagia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus.
1 secondary outcome
To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental area
Time frame: 8 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 25 Sep 2012.
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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, Inc
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 - U.S. and ATX-101 - EU 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 6 inclusion and 18 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 25 Sep 2012. 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: 8 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 25 Sep 2012.