Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male

NCT04138849 | Completed Phase 1 FDA Drug

• 1 other identifier: BBT877-IPF-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  The number of AEs.

  Up to Day 14.

Secondary Outcomes (3)

• Pharmacokinetics_AUC (the area under the curve)

  Day 1 to Day 4

• Pharmacokinetics_Cmax (peak concentration)

  Day 1 to Day 4

• Pharmacodynamics_plasma LPA (Lysophosphatidic acid)

  Day 1 to Day 4

Study Arms (4)

BBT-877 Low Dose

EXPERIMENTAL

Drug: BBT-877 single dose

BBT-877 Mid Dose

EXPERIMENTAL

Drug: BBT-877 single dose

BBT-877 High Dose

EXPERIMENTAL

Drug: BBT-877 single dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo single dose

Interventions

BBT-877 single dose DRUG

Oral capsule, single dose.

BBT-877 High Dose; BBT-877 Low Dose; BBT-877 Mid Dose

Placebo single dose DRUG

Oral capsule, single dose.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
• Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
• Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
• Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
• Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
• Must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after dosing of study treatment and refrain from donating sperm during this period
• Be first generation Japanese.

You may not qualify if:

• Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
• Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
• Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
• Donated plasma within 7 days of Day -1
• Estimated creatinine clearance \<80 mL/min
• Liver function tests (serum alkaline phosphatase \[ALP\], aspartate transaminase \[AST\], alanine aminotransferase \[ALT\]) and serum bilirubin (total and direct) 1.2 times above the upper limit of normal (ULN) at Screening or Day -1.
• Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -1.
• Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1.
• Positive cotinine test at Screening and Day -1.
• History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.

Sponsors & Collaborators

• Bridge Biotherapeutics, Inc.: lead
• KCRN Research, LLC: collaborator

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

ATX inhibitor BBT-877

Study Officials

• Jeong-Hyun Ryou, M.D., Ph.D.

  Bridge Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: October 1, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)