A Study to Investigate the Mass Balance of BTD-001

Phase 1

Completed

• Conditions: Molecular Mechanisms of Pharmacological Action
• Interventions: Drug: [14C]-BTD-001

• Registration Number: NCT03107013
• Lead Sponsor: Balance Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-27
• Study Start: 2017-04-03
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-BTD-001	[14C]-BTD-001	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
safety laboratory tests	Maximum 12 days	Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs
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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington, United Kingdom