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: Completed
• Conditions: Healthy
• Intervention / Treatment: Combination product: BT-600; Combination product: BT-600 Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5mg SAD	Combination product: BT-600; NaviCap device containing liquid formulation of Tofacitinib
Placebo Comparator: 5mg SAD placebo	Combination product: BT-600 Placebo; NaviCap device containing placebo formulation
Active Comparator: 10mg SAD	Combination product: BT-600; NaviCap device containing liquid formulation of Tofacitinib
Placebo Comparator: 10mg SAD placebo	Combination product: BT-600 Placebo; NaviCap device containing placebo formulation
Active Comparator: 5mg MAD	Combination product: BT-600; NaviCap device containing liquid formulation of Tofacitinib
Placebo Comparator: 5mg MAD placebo	Combination product: BT-600 Placebo; NaviCap device containing placebo formulation
Active Comparator: 10mg MAD	Combination product: BT-600; NaviCap device containing liquid formulation of Tofacitinib
Placebo Comparator: 10mg MAD placebo	Combination product: BT-600 Placebo; NaviCap device containing placebo formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of Treatment-Emergent Adverse Events.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Assessments	Maximum Plasma Concentration [Cmax] at Days 1, 2, 3, 4, 5, 6, 7.	Up to 7 days

Collaborators and Investigators

• Sponsor: Biora Therapeutics, Inc.
• Investigators: Study Director: Clinical Program Leader, Biora Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 23, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BT-600-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No