Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects

NCT03830125 | Completed Phase 1 FDA Drug

• 1 other identifier: BBT877-IPF-001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Autotaxin

Outcome Measures

Primary Outcomes (1)

• The number and severity of treatment emergent adverse events (TEAEs)

  To assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.

  7 days after the last dose

Secondary Outcomes (5)

• Peak Plasma Concentration of BBT-877 in plasma

  72 hours after the last dose

• Area under the plasma concentration versus time curve of BBT-877 in plasma

  72 hours after the last dose

• Peak Plasma Concentration of BBT-877 in plasma under fed condition.

  72 hours after the last dose

• Area under the plasma concentration versus time curve of BBT-877 in plasma under fed condition.

  72 hours after the last dose

• Raw and change-from-baseline values of plasma LPAs

  72 hours after the last dose

Study Arms (2)

Single Ascending Doses

EXPERIMENTAL

Drug: BBT-877, Single dose; Drug: Placebo group

Multiple Ascending Doses

EXPERIMENTAL

Drug: Placebo group; Drug: BBT-877, Multiple doses

Interventions

BBT-877, Single dose DRUG

Single dose of BBT-877, 5 dose levels, oral capsule

Single Ascending Doses

Placebo group DRUG

Placebo matched to BBT-877, oral capsule

Multiple Ascending Doses; Single Ascending Doses

BBT-877, Multiple doses DRUG

Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule

Multiple Ascending Doses

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
• BMI ≥ 18.5 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, as deemed by the PI or designee.
• No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and check-in.
• For a female, must be of non-childbearing potential and therefore must have undergone one of the following sterilization procedures, at least 6 months prior to the first dose:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dose of study drug. A male who has been vasectomized less than 4 months prior to the first dose must follow the same restrictions as a non-vasectomized male).
• If male, must agree to not donate sperm from the first dose until 90 days after the last dose of study drug.
• Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures.

You may not qualify if:

• Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose or regular alcohol consumption within 6 months prior to the first dose with an average weekly intake of greater than 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
• History of anemia or history of decreased red blood cells (RBC).
• Estimated creatinine clearance \<80 mL/min at screening.
• Liver function tests (serum ALT, AST, alkaline phosphatase) and serum bilirubin (total and direct) \> ULN.
• Baseline hemoglobin, hematocrit, RBC \< lower limit of normal at screening and Day -1.
• Female subjects who are pregnant or who are lactating.
• Positive urine drug or alcohol results at screening or check-in.
• Positive urine cotinine at screening.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• Unable to refrain from or anticipates the use of:
• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose and throughout the study. Hormone replacement therapy will not be allowed. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.

Sponsors & Collaborators

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

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

ATX inhibitor BBT-877

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

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: January 31, 2019
• First Posted: February 5, 2019
• Study Start: February 13, 2019
• Primary Completion: November 24, 2019
• Study Completion: November 24, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)