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Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156

NCT05220072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-28

No results posted yet for this study

Summary

The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into blood cells, provide additional safety and tolerability information and collect samples for metabolite profiling and structural identification.

Conditions

  • Parkinson Disease

Interventions

DRUG

Carbon-14 BIA 28-6156

Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14

Sponsors & Collaborators

  • Bial R&D Investments, S.A.

    lead INDUSTRY

Principal Investigators

  • Somasekhara Menakuru, MBBS,MS,MRCS,DPM,MFPM · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-08-28
Primary Completion
2021-10-16
Completion
2021-10-16

Countries

  • United Kingdom

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 NCT05220072 on ClinicalTrials.gov