HealthyPhase 1NCT06275464
BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
A Phase 1 study testing BT-600 in people with Healthy, run by Biora Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BT-600
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 23 Apr 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult male or female, 19-50 years of age.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the Investigator or designee.
- Laboratory results within normal range or not clinically significant as determined by the Investigator at Screening.
- Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol.
Who cannot join
- History of any illness, clinically significant medical condition, or disease, that in the opinion of the Investigator or designee might confound the results of the study or pose an additional risk to the subject by participation in the study.
- Major surgery within 4 weeks before study entry or anticipated during the study period.
- Has clinically significant active infectious disease or history of significant infectious disease.
- Participation in another clinical study within 30 days prior to the first dosing or five half-lives of the Investigational Product tested, whichever is longer. The window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- Female subjects with a positive pregnancy test at the Screening visit or at Check-in, or who are lactating.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.
The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.
BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement.
- Conditions
- Healthy
- Being tested
- BT-600, BT-600 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-600Combination product
NaviCap device containing liquid formulation of Tofacitinib
BT-600 PlaceboCombination product
NaviCap device containing placebo formulation
| Study group | Role | What they receive |
|---|---|---|
| 5mg SAD | Active comparator | Not described Receives: Combination Product: BT-600 |
| 5mg SAD placebo | Placebo comparator | Not described Receives: Combination Product: BT-600 Placebo |
| 10mg SAD | Active comparator | Not described Receives: Combination Product: BT-600 |
| 10mg SAD placebo | Placebo comparator | Not described Receives: Combination Product: BT-600 Placebo |
| 5mg MAD | Active comparator | Not described Receives: Combination Product: BT-600 |
| 5mg MAD placebo | Placebo comparator | Not described Receives: Combination Product: BT-600 Placebo |
| 10mg MAD | Active comparator | Not described Receives: Combination Product: BT-600 |
| 10mg MAD placebo | Placebo comparator | Not described Receives: Combination Product: BT-600 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Treatment-Emergent Adverse Events.
Measured: Up to 2 weeks
Secondary outcomes (1)
Pharmacokinetic (PK) Assessments
Maximum Plasma Concentration [Cmax] at Days 1, 2, 3, 4, 5, 6, 7.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start11 Jan 2024
- Primary completion18 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biora Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Program Leader, Study director, Biora Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275464
- Sponsor's protocol ID
- BT-600-101
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06275464
- Acronym / sponsor ID
- BT-600-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Biora Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 23 Feb 2024 (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 randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.
The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.
BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 5mg SAD | Active comparator | Combination Product: BT-600 |
| 5mg SAD placebo | Placebo comparator | Combination Product: BT-600 Placebo |
| 10mg SAD | Active comparator | Combination Product: BT-600 |
| 10mg SAD placebo | Placebo comparator | Combination Product: BT-600 Placebo |
| 5mg MAD | Active comparator | Combination Product: BT-600 |
| 5mg MAD placebo | Placebo comparator | Combination Product: BT-600 Placebo |
| 10mg MAD | Active comparator | Combination Product: BT-600 |
| 10mg MAD placebo | Placebo comparator | Combination Product: BT-600 Placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, adult male or female, 19-50 years of age.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the Investigator or designee.
- Laboratory results within normal range or not clinically significant as determined by the Investigator at Screening.
- Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol.
Key exclusion criteria (7 listed)
- History of any illness, clinically significant medical condition, or disease, that in the opinion of the Investigator or designee might confound the results of the study or pose an additional risk to the subject by participation in the study.
- Major surgery within 4 weeks before study entry or anticipated during the study period.
- Has clinically significant active infectious disease or history of significant infectious disease.
- Participation in another clinical study within 30 days prior to the first dosing or five half-lives of the Investigational Product tested, whichever is longer. The window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- Female subjects with a positive pregnancy test at the Screening visit or at Check-in, or who are lactating.
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 |
|---|---|---|
| BT-600NaviCap device containing liquid formulation of Tofacitinib | Combination product | 10mg MAD, 10mg SAD, 5mg MAD, 5mg SAD |
| BT-600 PlaceboNaviCap device containing placebo formulation | Combination product | 10mg MAD placebo, 10mg SAD placebo, 5mg MAD placebo, 5mg SAD placebo |
Primary outcome
Adverse Events
Time frame: Up to 2 weeks
Number of Treatment-Emergent Adverse Events.
1 secondary outcome
Pharmacokinetic (PK) Assessments
Time frame: Up to 7 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 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Clinical Program Leader study director
Biora 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 BT-600 in people with Healthy, run by Biora 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 4 inclusion and 7 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 21 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
Adverse Events (time frame: Up to 2 weeks). 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 21 Nov 2024.