Clinical trial NCT03107013: A Study to Investigate the Mass Balance of BTD-001
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Molecular Mechanisms of Pharmacological Action
Keywords: Mass Balance
Phase 1
Lead sponsor: Balance Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001
timeFrame: Maximum 12 days
measure: Metabolite Profiling
timeFrame: Maximum 12 days
Secondary outcomes:
measure: Determination of routes and rates of elimination of [14C]-BTD-001
timeFrame: Maximum 12 days
measure: Determination of the chemical structure of the "major" metabolites of [14C]-BTD-001
timeFrame: Maximum 12 days
measure: Evaluation of whole blood:plasma concentration ratios for total radioactivity
timeFrame: Maximum 12 days
measure: physical examination
timeFrame: Maximum 12 days
measure: safety laboratory tests
timeFrame: Maximum 12 days
measure: Vital signs
timeFrame: Maximum 12 days
measure: ECGs
timeFrame: Maximum 12 days
measure: AEs
timeFrame: Maximum 12 days
Other outcomes:
measure: Cmax
timeFrame: Maximum 12 days
measure: tmax
timeFrame: Maximum 12 days
measure: t1/2
timeFrame: Maximum 12 days
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: Quotient Clinical Ltd
name: Nand Signh, MD
role: PRINCIPAL_INVESTIGATOR
References: