Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

A Randomized, Double-Blind, Placebo and Moxifloxacin (Open-Label) Controlled, 4-Period, Crossover Study of the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316459

Enrollment

Registered

2006-04-20

Start date

2006-05-31

Completion date

Unknown

Last updated

2007-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Long QT Syndrome

Keywords

Healthy, Cardiac, Pharmacokinetics

Brief summary

To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.

Interventions

DRUGERB-041

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG. * Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.

Exclusion criteria

* A family history of long QT syndrome and/or cardiac death. * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.

Design outcomes

Primary

Measure	Time frame
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval	—

Secondary

Measure	Time frame
To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026