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

Parkinson Disease Clinical Trial

Official title:

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220072
• Other study ID #: BIA28-6156-106
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2021
• Est. completion date: October 16, 2021

Study information

• Verified date: January 2022
• Source: Bial R&D Investments, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open-label, single-dose, single period study in healthy male subjects. It is planned to enroll 6 subjects. All subjects will receive a single oral dose Carbon-14 BIA 28-6156. Blood samples will be collected at regular intervals for PK analysis, mass balance and metabolite profiling and identification from pre-dose up to 240 h post-dose. Urine and faecal samples will be collected at regular intervals for mass balance and metabolite profiling and identification from pre-dose until the mass balance criteria have been met.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 16, 2021
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males aged 30 to 65 years inclusive

• Body mass index (BMI) of 18.0 to 35.0 kg/m2

• Must be willing and able to communicate and participate in the whole study

• Must have regular bowel movements

• Must provide written informed consent

• Must agree to adhere to contraception requirements

Exclusion Criteria:

• Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1

• Subjects who are, or are immediate family members of, a study site or sponsor employee

• Evidence of current SARS-CoV-2 infection from results of diagnostic tests or from symptoms reported at screening or admission

• History of any drug or alcohol abuse in the past 2 years

• Regular alcohol consumption

• A confirmed positive alcohol breath test at screening or admission

• Current smokers and those who have smoked within the last 12 months.

• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

• Subjects with pregnant or lactating partners

• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.

• Subjects who do not have suitable veins for multiple venepunctures/cannulation

• Clinically significant abnormal clinical chemistry, haematology or urinalysis. Subjects with Gilbert's Syndrome are allowed.

• Confirmed positive drugs of abuse test result

• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results

• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation

• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

• Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active

• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration.

• Failure to satisfy the investigator of fitness to participate for any other reason

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Bial R&D Investments, S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance recovery of total radioactivity in all excreta (urine and faeces)	CumAe and Cum%Ae	Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
Primary	Collection of urine and faecal samples for total radioactivity	Total radioactivity for total recovery of Carbon-14 BIA28-6156	Urine and Faeces: Pre-dose until 288 hours post-dose
Primary	Collection of plasma samples for metabolite profiling	Collection of major metabolites for metabolite profiling of BIA28-6156	Pre-dose until 240 hours post-dose
Primary	Collection of plasma samples for structural identification	Identification of chemical structure of major metabolites of BIA28-6156	Pre-dose until 240 hours post-dose
Primary	Collection of whole blood samples for total radioactivity	Total radioactivity for total recovery of Carbon-14 BIA28-6156	Pre-dose until 240 hours post-dose
Secondary	Determination of routes and rates of elimination of Carbon-14 BIA 28-6156		Day 1 through Day 11
Secondary	Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating plasma total radioactivity and more than 10% of total radioactive dose		Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7
Secondary	Measurement of BIA 28-6156 PK parameters		Day 1 through Day 11
Secondary	Evaluation of whole blood: plasma concentration ratios for total radioactivity		Day 1 through Day 7
Secondary	Adverse events (AEs)		Screening through Day 11