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

• Sponsor: Balance Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03107013
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Molecular Mechanisms of Pharmacological Action	Drug: [14C]-BTD-001	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Apr 3, 2017
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Metabolite Profiling [Maximum 12 days]

   To provide plasma, urine and faecal samples for metabolite profiling and structural identification

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. physical examination [Maximum 12 days]

   Safety and tolerability of BTD-001 by assessing physical examination

5. safety laboratory tests [Maximum 12 days]

   Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs

6. Vital signs [Maximum 12 days]

   Safety and tolerability of BTD-001 by assessing vital signs

7. ECGs [Maximum 12 days]

   Safety and tolerability of BTD-001 by assessing ECGs

8. AEs [Maximum 12 days]

   Safety and tolerability of BTD-001 by assessing physical examination AEs

Other Outcome Measures

1. Cmax [Maximum 12 days]

   Maximum Observed Plasma Concentration

2. tmax [Maximum 12 days]

   time to reach maximum concentration

3. t1/2 [Maximum 12 days]

   elimination half-life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical	Ruddington		United Kingdom	NG11 6JS

Sponsors and Collaborators

• Balance Therapeutics

Investigators

• Principal Investigator: Nand Signh, MD, Quotient Clinical Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Balance Therapeutics
• ClinicalTrials.gov Identifier: NCT03107013
• Other Study ID Numbers: BTD-001 HV103
• First Posted: Apr 11, 2017
• Last Update Posted: Oct 24, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Balance Therapeutics: Mass Balance; Phase 1

Study Results

No Results Posted as of Oct 24, 2017