A Study to Investigate the Mass Balance of BTD-001 (HV103)

Balance Therapeutics

Status and phase

Completed

Phase 1

Conditions

Molecular Mechanisms of Pharmacological Action

Treatments

Drug: [14C]-BTD-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT03107013

BTD-001 HV103

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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