HealthyPhase 1NCT00618709
Dose-Escalation Safety and Pharmacokinetic Study 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 purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2009
- 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
- Healthy males or nonpregnant females
- Age 18 to 65
- Sufficient submental fat for injections
- Signed informed consent
Who cannot join
- Prior interventions in the chin or neck area
- History or presence of drug or alcohol abuse
- Treatment with an investigational agent within 30 days before the dose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area
The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
Read the detailed description
This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.
- Conditions
- Healthy
- Being tested
- ATX-101
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101Drug
ATX-101 single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid Receives: Drug: ATX-101 |
| Cohort 2 | Experimental | ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid Receives: Drug: ATX-101 |
| Cohort 3 | Experimental | 3 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid Receives: Drug: ATX-101 |
| Cohort 4 | Experimental | 3 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid Receives: Drug: ATX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by: Laboratory tests
Measured: 12 weeks
Safety assessed by: medical evaluations
Measured: 24 weeks
Safety assessed by: ECG results
Measured: 24 weeks
Secondary outcomes (1)
Pharmacokinetic profile
Cmax, tmax, AUC
Measured: 24 hours, before and after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJan 2009
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
- Allocation
- Non-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
- Dennis Swearingin, M.D., Principal investigator, MDS Pharma ServicesFrederick Beddingfield, M.D., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618709
- Sponsor's protocol ID
- ATX-101-07-08
- Other IDs
- ATX-101-07-08
- Status last verified
- May 2014
- First submitted
- 23 Jan 2008
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area
- ClinicalTrials.gov ID
- NCT00618709
- Acronym / sponsor ID
- ATX-101-07-08
- 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
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Feb 2008 (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 purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
Detailed description
This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ATX-101ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid |
| Cohort 2 | Experimental | Drug: ATX-101ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid |
| Cohort 3 | Experimental | Drug: ATX-1013 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid |
| Cohort 4 | Experimental | Drug: ATX-1013 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males or nonpregnant females
- Age 18 to 65
- Sufficient submental fat for injections
- Signed informed consent
Key exclusion criteria (3 listed)
- Prior interventions in the chin or neck area
- History or presence of drug or alcohol abuse
- Treatment with an investigational agent within 30 days before the dose
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-101ATX-101 single dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety assessed by: Laboratory tests
Time frame: 12 weeks
Safety assessed by: medical evaluations
Time frame: 24 weeks
Safety assessed by: ECG results
Time frame: 24 weeks
1 secondary outcome
Pharmacokinetic profile
Time frame: 24 hours, before and after dosing
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 30 May 2014.
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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.
Dennis Swearingin, M.D. principal investigator
MDS Pharma Services
Frederick Beddingfield, M.D. study director
Sponsor GmbH
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 4 inclusion and 3 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 30 May 2014. 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 assessed by: Laboratory tests (time frame: 12 weeks). 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 30 May 2014.