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Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics

NCT04994119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-08-06

No results posted yet for this study

Summary

The purpose of this study is:

* To investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9.
* To assess the effect of warfarin on the PK of BIA 5-1058.

Conditions

Interventions

DRUG

BIA 5-1058

Oral BIA 5-1058 (Zamicastat) 100 mg tablets

DRUG

Warfarin

Oral Warfarin (Coumadin) 5 mg film coated tablets

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2018-05-23
Completion
2018-05-23

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT04994119 on ClinicalTrials.gov