Trials Sponsors Conditions Drugs Pricing

Conditions

Congestive Heart Failure Hypertension

Outcome Measures

Primary Outcomes (3)

urinary excretion of BIA 5-453 associated radioactivity
following a single 600 mg oral dose labeled with 98 μCi of \[14C\]
pre-dose, then it was collected from 0-4, 4-8, 8-24, 24-48, 48-72, 72-120, 120-168, 168-216, and 216-264 hours post-dose.
faecal excretion of BIA 5-453 associated radioactivity
baseline period. Following dose, each faeces sample was collected during the 264 hours post-dose period.
following a single 600 mg oral dose labeled with 98 μCi of [14C]
amount of BIA 5-453 associated radioactivity present in the expired air
following a single 600 mg oral dose labeled with 98 μCi of \[14C\]
baseline, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h 6h, 8h, 12h and 24h post-dose

Study Arms (1)

Etamicastat

EXPERIMENTAL

Single administration. 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 50 mg, hard gelatina capsules

Drug: BIA-5-453

Interventions

BIA-5-453Drug

Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).

Etamicastat

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 55 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy Caucasian male subjects, 40-55 years of age.
Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 160 mmHg systolic, 50 95 mmHg diastolic and pulse rate: 50 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.

Sponsors & Collaborators

Bial - Portela C S.A.
Industrylead

Study Sites (1)

Swiss Pharma Contract Ltd.

Allschwil, CH-4123, Switzerland

MeSH Terms

Conditions

HypertensionHeart Failure

Interventions

etamicastat

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 9, 2017

Study Start

September 2008

Date type not reported

This date has not been verified as actual or estimated.

Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Etamicastat

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Etamicastat

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations