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OpenTrials
Completed

NCT Number: NCT00618709

Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATX-101

Drug

ATX-101 single dose

Primary outcomes

  1. Safety assessed by: Laboratory tests

    Time frame: 12 weeks

  2. Safety assessed by: medical evaluations

    Time frame: 24 weeks

  3. Safety assessed by: ECG results

    Time frame: 24 weeks

Secondary outcomes

  1. Pharmacokinetic profile

    Time frame: 24 hours, before and after dosing

    Cmax, tmax, AUC

Other outcomes

  1. Pain assessed by visual analog scale

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Kythera Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 20, 2008
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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