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A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

NCT03596294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-10-23

No results posted yet for this study

Summary

A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan

Conditions

  • Healthy Subjects

Interventions

DRUG

Clazosentan

Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h

DRUG

Rifampicin

Single i.v. dose of 600 mg rifampicin for 30 min

OTHER

Saline (0.9% sodium chloride)

Single i.v infusion of 500 mL saline for 30 min

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2018-08-03
Completion
2018-08-03
FDA Drug
Yes

Countries

  • Netherlands

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 NCT03596294 on ClinicalTrials.gov