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

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

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.

Study Overview

• Status: Completed
• Conditions: Molecular Mechanisms of Pharmacological Action
• Intervention / Treatment: Drug: [14C]-BTD-001

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Ruddington, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-BTD-001	Drug: [14C]-BTD-001; Carbon-14 labeled BTD-001

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Plasma Concentration	Maximum 12 days
tmax	time to reach maximum concentration	Maximum 12 days
t1/2	elimination half-life	Maximum 12 days

Collaborators and Investigators

• Sponsor: Balance Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Phase 1; Mass Balance
• Other Study ID Numbers: BTD-001 HV103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No