Food EffectPhase 1NCT03150498
A Food Effects Study and Optional Multi Dose Study to Assess PK of BTD-001
A Phase 1 study testing BTD-001 in people with Food Effect and Healthy, run by Balance Therapeutics at 1 site in United Kingdom.
Trial summary
This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect, Healthy
- What is being tested?
- BTD-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2017to 12 Jul 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and non-pregnant, non-lactating females aged 18-55 years old
- BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
- 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.
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- 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 of >430 msec in males and >450 msec in females
- 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,hormone replacement therapy and hormonal contraception) 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.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001
This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data.
Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.
Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001
- Conditions
- Food Effect, Healthy
- Being tested
- BTD-001
- Keywords
- Food Effect, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTD-001Drug
BTD-001 in fed vs fasted state
| Study group | Role | What they receive |
|---|---|---|
| BTD-001 (fed) | Experimental | Not described Receives: Drug: BTD-001 |
| BTD-001 (fasted) | Experimental | Not described Receives: Drug: BTD-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
Maximum Observed Plasma Concentration
Measured: [Maximum 30 days]
Part 1 & Part 2 - Tmax of BTD-001 and major metabolites
Time to Maximum Observed Plasma Concentration
Measured: [Maximum 30 days]
Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites
Area Under the Curve for Observed Plasma Concentration
Measured: [Maximum 30 days]
Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites
elimination half-life
Measured: [Maximum 30 days]
Secondary outcomes (6)
Physical Examination
Safety and tolerability of BTD-001 by assessing physical examination
Measured: [Maximum 30 days]
Vital Signs
Safety and tolerability of BTD-001 by assessing vital signs
Measured: [Maximum 30 days]
ECG
Safety and tolerability of BTD-001 by assessing ECG
Measured: [Maximum 30 days]
Adverse Events
Safety and tolerability of BTD-001 by assessing AEs
Measured: [Maximum 30 days]
Safety Lab Test
Safety and tolerability of BTD-001 by assessing safety lab tests
Measured: [Maximum 30 days]
Likert Scales
To assess BTD-001 withdrawal in healthy volunteers
Measured: [Maximum 30 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start3 May 2017
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food EffectStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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
- NCT03150498
- Sponsor's protocol ID
- BTD-001 HV104
- Status last verified
- Oct 2017
- First submitted
- 2 May 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
- A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001
- ClinicalTrials.gov ID
- NCT03150498
- Acronym / sponsor ID
- BTD-001 HV104
- Conditions
- Food Effect, Healthy
- Keywords
- Food Effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Balance TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 12 May 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 study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data.
Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.
Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTD-001 (fed) | Experimental | Drug: BTD-001 |
| BTD-001 (fasted) | Experimental | Drug: BTD-001 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult males and non-pregnant, non-lactating females aged 18-55 years old
- BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
- Provide written consent
- Agrees to protocol specified contraception
Key exclusion criteria (19 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 |
|---|---|---|
| BTD-001BTD-001 in fed vs fasted state | Drug | BTD-001 (fasted), BTD-001 (fed) |
Primary outcome
Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
Time frame: [Maximum 30 days]
Maximum Observed Plasma Concentration
Part 1 & Part 2 - Tmax of BTD-001 and major metabolites
Time frame: [Maximum 30 days]
Time to Maximum Observed Plasma Concentration
Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites
Time frame: [Maximum 30 days]
Area Under the Curve for Observed Plasma Concentration
Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites
Time frame: [Maximum 30 days]
elimination half-life
6 secondary outcomes
Physical Examination
Time frame: [Maximum 30 days]
Vital Signs
Time frame: [Maximum 30 days]
ECG
Time frame: [Maximum 30 days]
Adverse Events
Time frame: [Maximum 30 days]
Safety Lab Test
Time frame: [Maximum 30 days]
Likert Scales
Time frame: [Maximum 30 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 BTD-001 in people with Food Effect and Healthy, 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 4 inclusion and 19 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?
Part 1 & Part 2 - Cmax of BTD-001 and major metabolites (time frame: [Maximum 30 days]). The study lists 4 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; AzTrials last refreshed its copy on 28 Oct 2026.