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Open-Label Pharmacokinetic Study of Final Formulations of ATX-101

NCT01632917 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-09-25

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ATX-101 - U.S.

US ATX-101, 10 mg/mL, one dosing session in the submental area

DRUG

ATX-101 - EU

EU ATX-101, 10 mg/mL, one dosing session in the submental area

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Patricia Walker, MD, PhD · Kythera Biopharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632917 on ClinicalTrials.gov