- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275464
BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Angie Badgett, BS, MBA
- Phone Number: 402-437-6351
- Email: angie.badgett@celerion.com
Study Contact Backup
- Name: Brandon Lester, BS
- Phone Number: 402-437-4978
- Email: brandon.lester@celerion.com
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Recruiting
- Celerion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 5mg SAD
|
NaviCap device containing liquid formulation of Tofacitinib
|
Placebo Comparator: 5mg SAD placebo
|
NaviCap device containing placebo formulation
|
Active Comparator: 10mg SAD
|
NaviCap device containing liquid formulation of Tofacitinib
|
Placebo Comparator: 10mg SAD placebo
|
NaviCap device containing placebo formulation
|
Active Comparator: 5mg MAD
|
NaviCap device containing liquid formulation of Tofacitinib
|
Placebo Comparator: 5mg MAD placebo
|
NaviCap device containing placebo formulation
|
Active Comparator: 10mg MAD
|
NaviCap device containing liquid formulation of Tofacitinib
|
Placebo Comparator: 10mg MAD placebo
|
NaviCap device containing placebo formulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to 2 weeks
|
Number of Treatment-Emergent Adverse Events.
|
Up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic (PK) Assessments
Time Frame: Up to 7 days
|
Maximum Plasma Concentration [Cmax] at Days 1, 2, 3, 4, 5, 6, 7.
|
Up to 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Program Leader, Biora Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BT-600-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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