Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275464
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-08
Brief Title:
BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
Sponsor:
Biora Therapeutics Inc
Organization:
Biora Therapeutics Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 bodys effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants
BT-600 is a swallowable drugdevice 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
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 bodys effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants
BT-600 is a swallowable drugdevice 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None