Dermatitis, AtopicPhase 1NCT02590289
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
A Phase 1 study testing BBI-5000 in people with Dermatitis, Atopic, run by Fresh Tracks Therapeutics, Inc. at 1 site in United States.
Trial summary
To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- BBI-5000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2015
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker
- Medically healthy
- 32.0 >= BMI >= 18.5 kg/m^2
- Weight >= 50 kg for males
- Weight >= 45 kg for females
- For a female of childbearing potential: either be sexually inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method as dictated by the study
- Willing to comply with protocol and understands study procedures outlined in the ICF
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems
- History or presence of medical or psychiatric disease
- History of any illness that might confound the results of the study
- History or presence of alcoholism or drug abuse
- History or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient
- History or presence of lactose intolerance
Show all 13Show fewer
- Pregnant or lactating females
- Seated blood pressure less than 90/40 mmHg or greater than 140/90 mmHg
- Seated heart rate lower than 40 bpm or higher than 99 bpm
- Unable to refrain from or anticipates the use of any drug
- Diet incompatible with the on-study diet
- Donation of blood or significant blood loss within 56 days prior to the first study dose
- Participation in another clinical trial within 28 days prior to the first study dose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of BBI-5000 Capsules in Healthy Adult Subjects
To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
Read the detailed description
This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.
Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.
PK and PD will be assessed by blood sampling through 72 hours postdose.
Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.
- Conditions
- Dermatitis, Atopic
- Being tested
- BBI-5000
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-5000Drug
BBI-5000 low dose, middle dose, or high doses
| Study group | Role | What they receive |
|---|---|---|
| BBI-5000 Dose 1 | Experimental | Low dose of BBI-5000 Receives: Drug: BBI-5000 |
| BBI-5000 Dose 2 | Experimental | Middle dose of BBI-5000 Receives: Drug: BBI-5000 |
| BBI-5000 Dose 3 | Experimental | High dose of BBI-5000 Receives: Drug: BBI-5000 |
| BBI-5000 Dose 4 | Experimental | High dose of BBI-5000 Receives: Drug: BBI-5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
Measured: Week 4
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
Measured: Week 4
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
Measured: Week 4
Time of Occurrence of Cmax (Tmax)
Measured: Week 4
Clearance (CL/F)
Measured: Week 4
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
Measured: Week 4
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
Measured: Week 4
Half-life for BBI-5000 and the 3 metabolites
Measured: Week 4
Secondary outcomes (1)
Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresh Tracks Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Hussey, PharmD, Study director, Fresh Tracks Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590289
- Sponsor's protocol ID
- BBI-5000-CL-103
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2015
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of BBI-5000 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02590289
- Acronym / sponsor ID
- BBI-5000-CL-103
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fresh Tracks Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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.
To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
Detailed description
This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.
Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.
PK and PD will be assessed by blood sampling through 72 hours postdose.
Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BBI-5000 Dose 1 | Experimental | Drug: BBI-5000Low dose of BBI-5000 |
| BBI-5000 Dose 2 | Experimental | Drug: BBI-5000Middle dose of BBI-5000 |
| BBI-5000 Dose 3 | Experimental | Drug: BBI-5000High dose of BBI-5000 |
| BBI-5000 Dose 4 | Experimental | Drug: BBI-5000High dose of BBI-5000 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-smoker
- Medically healthy
- 32.0 >= BMI >= 18.5 kg/m^2
- Weight >= 50 kg for males
- Weight >= 45 kg for females
Key exclusion criteria (13 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems
- History or presence of medical or psychiatric disease
- History of any illness that might confound the results of the study
- History or presence of alcoholism or drug abuse
- History or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient
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 |
|---|---|---|
| BBI-5000BBI-5000 low dose, middle dose, or high doses | Drug | BBI-5000 Dose 1, BBI-5000 Dose 2, BBI-5000 Dose 3, BBI-5000 Dose 4 |
Primary outcome
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
Time frame: Week 4
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
Time frame: Week 4
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
Time frame: Week 4
Time of Occurrence of Cmax (Tmax)
Time frame: Week 4
Clearance (CL/F)
Time frame: Week 4
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
Time frame: Week 4
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
Time frame: Week 4
Half-life for BBI-5000 and the 3 metabolites
Time frame: Week 4
1 secondary outcome
Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results
Time frame: Week 4
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 19 Jan 2023.
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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.
Elizabeth Hussey, PharmD study director
Fresh Tracks Therapeutics, Inc.
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 BBI-5000 in people with Dermatitis, Atopic, run by Fresh Tracks Therapeutics, Inc. at 1 site in United States.
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 7 inclusion and 13 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 19 Jan 2023. 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 States. 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?
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites (time frame: Week 4). The study lists 8 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 19 Jan 2023.