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Evaluation of the Effect of ATX-101 on QT/QTc Intervals

NCT01706679 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2013-11-14

No results posted yet for this study

Summary

To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).

Conditions

  • Healthy

Interventions

DRUG

ATX-101 (10 mg/ml)

DRUG

ATX-101 (20 mg/ml)

DRUG

Moxifloxacin (400 mg)

DRUG

Placebo vehicle (PBS)

Sponsors & Collaborators

  • Kythera Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Royce Morrison, MD, PhD · Comprehensive Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-02-28
Completion
2013-06-30

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 NCT01706679 on ClinicalTrials.gov