Molecular Mechanisms of Pharmacological ActionPhase 1HV103NCT03107013
A Study to Investigate the Mass Balance of BTD-001
A Phase 1 study testing [14C]-BTD-001 in people with Molecular Mechanisms of Pharmacological Action, run by Balance Therapeutics at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Molecular Mechanisms of Pharmacological Action
- What is being tested?
- [14C]-BTD-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2017to 1 May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- [14C]-BTD-001
- Keywords
- Mass Balance, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BTD-001Drug
Carbon-14 labeled BTD-001
| Study group | Role | What they receive |
|---|---|---|
| [14C]-BTD-001 | Experimental | Not described Receives: Drug: [14C]-BTD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Maximum 12 days
Metabolite Profiling
To provide plasma, urine and faecal samples for metabolite profiling and structural identification
Measured: Maximum 12 days
Secondary outcomes (8)
Determination of routes and rates of elimination of [14C]-BTD-001
[14C]-BTD-001 metabolite profiling and structural identification in plasma, urine and faeces
Measured: 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
Measured: 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
Measured: Maximum 12 days
physical examination
Safety and tolerability of BTD-001 by assessing physical examination
Measured: Maximum 12 days
safety laboratory tests
Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs
Measured: Maximum 12 days
Vital signs
Safety and tolerability of BTD-001 by assessing vital signs
Measured: Maximum 12 days
ECGs
Safety and tolerability of BTD-001 by assessing ECGs
Measured: Maximum 12 days
AEs
Safety and tolerability of BTD-001 by assessing physical examination AEs
Measured: Maximum 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start3 Apr 2017
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular Mechanisms of Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balance Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nand Signh, MD, Principal investigator, Quotient Clinical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107013
- Sponsor's protocol ID
- BTD-001 HV103
- Acronym
- HV103
- Status last verified
- Oct 2017
- First submitted
- 27 Mar 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03107013
- Acronym / sponsor ID
- HV103 / BTD-001 HV103
- Keywords
- Mass Balance, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Balance TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-BTD-001 | Experimental | Drug: [14C]-BTD-001 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-BTD-001Carbon-14 labeled BTD-001 | Drug | [14C]-BTD-001 |
Primary outcome
Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001
Time frame: Maximum 12 days
The percentage of radioactive dose of [14C] radiolabelled BTD-001 recovered in urine, faeces, and plasma
Metabolite Profiling
Time frame: Maximum 12 days
To provide plasma, urine and faecal samples for metabolite profiling and structural identification
8 secondary outcomes
Determination of routes and rates of elimination of [14C]-BTD-001
Time frame: Maximum 12 days
Determination of the chemical structure of the "major" metabolites of [14C]-BTD-001
Time frame: Maximum 12 days
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Maximum 12 days
physical examination
Time frame: Maximum 12 days
safety laboratory tests
Time frame: Maximum 12 days
Vital signs
Time frame: Maximum 12 days
ECGs
Time frame: Maximum 12 days
AEs
Time frame: Maximum 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nand Signh, MD principal investigator
Quotient Clinical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-BTD-001 in people with Molecular Mechanisms of Pharmacological Action, run by Balance Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001 (time frame: Maximum 12 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.