BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
Public ClinicalTrials.gov record NCT06275464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06275464
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 19 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2024
- Primary completion
- Apr 17, 2024
- Completion
- Apr 22, 2024
- Last update posted
- Nov 20, 2024
2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06275464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2024 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06275464 live on ClinicalTrials.gov.