Molecular Mechanisms of Pharmacological Action
Conditions
Keywords
Mass Balance, Phase 1
Brief summary
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.
Interventions
DRUG[14C]-BTD-001
Carbon-14 labeled BTD-001
Sponsors
Balance Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001 | Maximum 12 days | The percentage of radioactive dose of \[14C\] radiolabelled BTD-001 recovered in urine, faeces, and plasma |
| Metabolite Profiling | Maximum 12 days | To provide plasma, urine and faecal samples for metabolite profiling and structural identification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the chemical structure of the major metabolites of [14C]-BTD-001 | Maximum 12 days | Identification of the chemical structure of each metabolite accounting for more than 10% (by AUC) of circulating total radioactivity |
| Evaluation of whole blood:plasma concentration ratios for total radioactivity | Maximum 12 days | To evaluate the extent of distribution of total radioactivity into blood cells |
| physical examination | Maximum 12 days | Safety and tolerability of BTD-001 by assessing physical examination |
| Determination of routes and rates of elimination of [14C]-BTD-001 | Maximum 12 days | \[14C\]-BTD-001 metabolite profiling and structural identification in plasma, urine and faeces |
| Vital signs | Maximum 12 days | Safety and tolerability of BTD-001 by assessing vital signs |
| ECGs | Maximum 12 days | Safety and tolerability of BTD-001 by assessing ECGs |
| AEs | Maximum 12 days | Safety and tolerability of BTD-001 by assessing physical examination AEs |
| safety laboratory tests | Maximum 12 days | Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Maximum 12 days | Maximum Observed Plasma Concentration |
| t1/2 | Maximum 12 days | elimination half-life |
| tmax | Maximum 12 days | time to reach maximum concentration |
Countries
United Kingdom
Outcome results
None listed