A Study to Investigate the Mass Balance of BTD-001

Molecular Mechanisms of Pharmacological Action Clinical Trial

— HV103  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107013
• Other study ID #: BTD-001 HV103
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2017
• Last updated: October 20, 2017
• Start date: April 3, 2017
• Est. completion date: May 1, 2017

Study information

• Verified date: October 2017
• Source: Balance Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Molecular Mechanisms of Pharmacological Action

Intervention

Drug:
• [14C]-BTD-001
Carbon-14 labeled BTD-001

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Balance Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cmax	Maximum Observed Plasma Concentration	Maximum 12 days
Other	tmax	time to reach maximum concentration	Maximum 12 days
Other	t1/2	elimination half-life	Maximum 12 days
Primary	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
Primary	Metabolite Profiling	To provide plasma, urine and faecal samples for metabolite profiling and structural identification	Maximum 12 days
Secondary	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
Secondary	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
Secondary	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
Secondary	physical examination	Safety and tolerability of BTD-001 by assessing physical examination	Maximum 12 days
Secondary	safety laboratory tests	Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs	Maximum 12 days
Secondary	Vital signs	Safety and tolerability of BTD-001 by assessing vital signs	Maximum 12 days
Secondary	ECGs	Safety and tolerability of BTD-001 by assessing ECGs	Maximum 12 days
Secondary	AEs	Safety and tolerability of BTD-001 by assessing physical examination AEs	Maximum 12 days