A Study to Investigate the Mass Balance of BTD-001

NCT03107013 | Completed Phase 1 FDA Drug

• 1 other identifier: BTD-001 HV103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 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.

Conditions

Molecular Mechanisms of Pharmacological Action

Keywords

Mass Balance; Phase 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Determination of routes and rates of elimination of [14C]-BTD-001

  Maximum 12 days

• Determination of the chemical structure of the "major" metabolites of [14C]-BTD-001

  Maximum 12 days

• Evaluation of whole blood:plasma concentration ratios for total radioactivity

  Maximum 12 days

• physical examination

  Maximum 12 days

• safety laboratory tests

  Maximum 12 days

Other Outcomes (3)

• Cmax

  Maximum 12 days

• tmax

  Maximum 12 days

• t1/2

  Maximum 12 days

Study Arms (1)

[14C]-BTD-001

EXPERIMENTAL

Drug: [14C]-BTD-001

Interventions

[14C]-BTD-001 DRUG

Carbon-14 labeled BTD-001

[14C]-BTD-001

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balance Therapeutics: lead

Study Sites (1)

Quotient Clinical

Ruddington, NG11 6JS, United Kingdom

Location

Study Officials

• Nand Signh, MD

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 11, 2017
• Study Start: April 3, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

GB (1)