- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00618709
Dose-Escalation Safety and Pharmacokinetic Study of ATX-101
May 28, 2014 updated by: Kythera Biopharmaceuticals
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- MDS Pharma Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males or nonpregnant females
- Age 18 to 65
- Sufficient submental fat for injections
- Signed informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
|
ATX-101 single dose
|
Experimental: Cohort 2
ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
|
ATX-101 single dose
|
Experimental: Cohort 3
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
|
ATX-101 single dose
|
Experimental: Cohort 4
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
|
ATX-101 single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety assessed by: Laboratory tests
Time Frame: 12 weeks
|
12 weeks
|
Safety assessed by: medical evaluations
Time Frame: 24 weeks
|
24 weeks
|
Safety assessed by: ECG results
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile
Time Frame: 24 hours, before and after dosing
|
Cmax, tmax, AUC
|
24 hours, before and after dosing
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain assessed by visual analog scale
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dennis Swearingin, M.D., MDS Pharma Services
- Study Director: Frederick Beddingfield, M.D., Sponsor GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
January 23, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 20, 2008
Study Record Updates
Last Update Posted (Estimate)
May 30, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ATX-101-07-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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