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Completed

NCT Number: NCT06275464

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.

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BT-600

Combination Product

NaviCap device containing liquid formulation of Tofacitinib

BT-600 Placebo

Combination Product

NaviCap device containing placebo formulation

Primary outcomes

  1. Adverse Events

    Time frame: Up to 2 weeks

    Number of Treatment-Emergent Adverse Events.

Secondary outcomes

  1. Pharmacokinetic (PK) Assessments

    Time frame: Up to 7 days

    Maximum Plasma Concentration [Cmax] at Days 1, 2, 3, 4, 5, 6, 7.

Sponsors and collaborators

Lead sponsor

Biora Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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