A Study to Investigate the Mass Balance of BTD-001

Study Overview
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Brief Summary
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This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.

Official Title
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An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BTD-001 in Healthy Male Subjects

Conditions
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Molecular Mechanisms of Pharmacological Action

Intervention / Treatment
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* Drug: [14C]-BTD-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males aged 30-65 years old BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant Regular daily bowel movements Provide written consent Agrees to protocol specified contraception Exclusion Criteria: Received any investigational treatment within last 3 months Subjects who are study site employees, or immediate family members of a study site or sponsor employee Subjects who have previously been enrolled in this study History of any drug or alcohol abuse in the past 2 years Regular alcohol consumption in males >21 units per week Current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months. 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. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening Clinically significant abnormal lab results Positive drugs of abuse test result Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results Evidence of renal impairment at screening History of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years Clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour History of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism Subjects with QT interval corrected for heart rate according to Fridericia's formula >450 msec Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active Donation or loss of greater than 400 mL of blood within the previous 3 months Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol) or herbal remedies Failure to satisfy the investigator of fitness to participate for any other reason

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-BTD-001<br> | Drug: [14C]-BTD-001<br>* Carbon-14 labeled BTD-001<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001 | The percentage of radioactive dose of [14C] radiolabelled BTD-001 recovered in urine, faeces, and plasma | Maximum 12 days | 
| Metabolite Profiling | To provide plasma, urine and faecal samples for metabolite profiling and structural identification | Maximum 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of routes and rates of elimination of [14C]-BTD-001 | [14C]-BTD-001 metabolite profiling and structural identification in plasma, urine and faeces | Maximum 12 days | 
| Determination of the chemical structure of the major metabolites of [14C]-BTD-001 | Identification of the chemical structure of each metabolite accounting for more than 10% (by AUC) of circulating total radioactivity | Maximum 12 days | 
| Evaluation of whole blood:plasma concentration ratios for total radioactivity | To evaluate the extent of distribution of total radioactivity into blood cells | Maximum 12 days | 
| physical examination | Safety and tolerability of BTD-001 by assessing physical examination | Maximum 12 days | 
| safety laboratory tests | Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs | Maximum 12 days | 
| Vital signs | Safety and tolerability of BTD-001 by assessing vital signs | Maximum 12 days | 
| ECGs | Safety and tolerability of BTD-001 by assessing ECGs | Maximum 12 days | 
| AEs | Safety and tolerability of BTD-001 by assessing physical examination AEs | Maximum 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mass Balance, Phase 1