Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

NCT04138836 | Completed Phase 1 FDA Drug

• 1 other identifier: BBT877-IPF-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetics of BBT-877, in healthy adult subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• AUC (the area under the curve) [Pharmacokinetics]

  AUC for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3)

  Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2

• Cmax (peak concentration) [Pharmacokinetics]

  Cmax for midazolam and 1-OH-midazolam with and without BBT-877 (Arm 1), and for BBT-877 with and without itraconazole (Arm 2) or esomeprazole (Arm 3)

  Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2

Secondary Outcomes (2)

• Plasma LPA (Lysophosphatidic acid) concentration [Pharmacodynamics (Arm 2 and 3)]

  Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2

• Incidence of adverse events [Safety and tolerability]

  Up to 14 days after the last study drug administration

Study Arms (3)

Midazolam

EXPERIMENTAL

Drug: BBT-877; Drug: Midazolam

Itraconazole

EXPERIMENTAL

Drug: BBT-877; Drug: Itraconazole

Esomeprazole

EXPERIMENTAL

Drug: BBT-877; Drug: Esomeprazole

Interventions

BBT-877 DRUG

BBT-877 oral capsule.

Esomeprazole; Itraconazole; Midazolam

Midazolam DRUG

Midazolam oral syrup.

Midazolam

Itraconazole DRUG

Itraconazole oral capsule.

Itraconazole

Esomeprazole DRUG

Esomeprazole oral capsule.

Esomeprazole

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 first check-in.
• For a female, must be of non-childbearing potential.
• 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.
• If male, must agree to not donate sperm from the first dose until 90 days after the last dose of study drug(s).
• Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures, and be willing and able to comply with the protocol requirements as outlined in the ICF.

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.
• 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) \> upper limit of normal at screening or first check-in.
• Baseline hemoglobin, hematocrit, RBC \< lower limit of normal at screening and Day -1 of Period 1.
• Female subjects who are of childbearing potential.
• Female subjects who are pregnant or lactating.
• Positive urine drug or alcohol results at screening or first 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).

Sponsors & Collaborators

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

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

ATX inhibitor BBT-877; Midazolam; Itraconazole; Esomeprazole

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles

Study Officials

• Jeong-Hyun Ryou, M.D., Ph.D.

  Bridge Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: September 17, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)