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Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)

NCT04316143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-10-15

Study results available
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Summary

This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease

Conditions

Interventions

DRUG

Oral zamicastat

Tablets for oral administration under fed conditions containing 100 mg of zamicastat

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-10-20
Completion
2021-10-20

Countries

  • Austria
  • Germany
  • Italy
  • Portugal
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT04316143 on ClinicalTrials.gov