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The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers

NCT04019652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-07-15

No results posted yet for this study

Summary

This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.

Conditions

Interventions

DRUG

CS-3150

Single, oral administration; 10-mg or 40-mg dose

DRUG

Moxifloxacin

Single, oral administration; 400 mg-tablet

DRUG

Placebo matching moxifloxacin tablet

Placebo tablets matching moxifloxacin tablets

DRUG

Placebo matching CS-3150

Placebo tablets matching CS-3150 tablets

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2015-12-23
Completion
2015-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04019652 on ClinicalTrials.gov