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Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

Sponsor
Kythera Biopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00618709
Collaborator
(none)
24
Enrollment
1
Location
4
Arms
12
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
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
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid

Drug: ATX-101
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

Drug: ATX-101
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

Drug: ATX-101
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

Drug: ATX-101
ATX-101 single dose

Outcome Measures

Primary Outcome Measures

  1. Safety assessed by: Laboratory tests [12 weeks]

  2. Safety assessed by: medical evaluations [24 weeks]

  3. Safety assessed by: ECG results [24 weeks]

Secondary Outcome Measures

  1. Pharmacokinetic profile [24 hours, before and after dosing]

    Cmax, tmax, AUC

Other Outcome Measures

  1. Pain assessed by visual analog scale [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MDS Pharma Services Tempe Arizona United States 85283

Sponsors and Collaborators

  • Kythera Biopharmaceuticals

Investigators

  • Principal Investigator: Dennis Swearingin, M.D., MDS Pharma Services
  • Study Director: Frederick Beddingfield, M.D., Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kythera Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00618709
Other Study ID Numbers:
  • ATX-101-07-08
  • ATX-101-07-08
First Posted:
Feb 20, 2008
Last Update Posted:
May 30, 2014
Last Verified:
May 1, 2014
Keywords provided by Kythera Biopharmaceuticals
Healthy volunteers

Study Results

No Results Posted as of May 30, 2014