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Absorption, Distribution, Metabolism and Excretion of BIA 5-1058

NCT04991181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-05

No results posted yet for this study

Summary

the purpose of this study is:

* to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7 Megabecquerel (MBq) of radiocarbon;
* to determine the pharmacokinetics (PK) of total radioactivity (TRA) in plasma and whole blood and to assess the blood-to-plasma ratio;
* to determine the PK of BIA 5-1058 and its metabolites in plasma.

Conditions

Interventions

DRUG

400 mg BIA 5-1058

Capsules, oral administered to subjects between 08:00 and 09:00 hours in the morning of Day 1after an overnight fast of at least 10 hours. The study drug was swallowed together with 240 mL tap water (room temperature).

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-05-24
Completion
2017-05-24

Countries

  • Netherlands

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 NCT04991181 on ClinicalTrials.gov