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Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart

NCT05933447 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-10-03

No results posted yet for this study

Summary

To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

Rodatristat Ethyl

Oral, Tablet, 300 mg QD, 300 mg BID, 600 mg BID, 900 mg BID, 900 mg QD

DRUG

Moxifloxacin

Oral, Tablet, 400 mg QD

DRUG

Placebo for Rodatristat

Oral, Tablet, O mg QD, 0 mg BID

DRUG

Placebo for Moxifloxacin

Oral, Tablet, 0 mg QD

Sponsors & Collaborators

  • Altasciences Clinical Kansas, Inc.

    collaborator UNKNOWN

  • Altavant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Kankam, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2023-07-28
Completion
2023-07-28
FDA Drug
Yes

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 NCT05933447 on ClinicalTrials.gov