CClinicalTrials.gg
CompletedNCT04138836Updated Jan 18, 2020

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

A Phase 1 interventional study of BBT-877 and Midazolam in Healthy Participants, sponsored by Bridge Biotherapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Bridge Biotherapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2019, 6 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Bridge Biotherapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
  2. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
  3. BMI ≥ 18.5 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at screening.
  4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, as deemed by the PI or designee.
  5. No clinically significant history or presence of ECG findings as judged by the PI or qualified designee at screening and first check-in.
  6. For a female, must be of non-childbearing potential.
  7. 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.
  8. If male, must agree to not donate sperm from the first dose until 90 days after the last dose of study drug(s).
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
  3. 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.
  4. 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.
  5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
  6. History of anemia or history of decreased red blood cells (RBC).
  7. Estimated creatinine clearance \<80 mL/min at screening.
  8. Liver function tests (serum ALT, AST, alkaline phosphatase) and serum bilirubin (total and direct) > upper limit of normal at screening or first check-in.
  9. Baseline hemoglobin, hematocrit, RBC \< lower limit of normal at screening and Day -1 of Period 1.
  10. Female subjects who are of childbearing potential.
  11. Female subjects who are pregnant or lactating.
  12. Positive urine drug or alcohol results at screening or first check-in.
  13. Positive urine cotinine at screening.
  14. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Midazolam

    Drug: BBT-877 · Drug: Midazolam

  • Experimental
    Itraconazole

    Drug: BBT-877 · Drug: Itraconazole

  • Experimental
    Esomeprazole

    Drug: BBT-877 · Drug: Esomeprazole

Interventions

  • DrugBBT-877

    BBT-877 oral capsule.

  • DrugMidazolam

    Midazolam oral syrup.

  • DrugItraconazole

    Itraconazole oral capsule.

  • DrugEsomeprazole

    Esomeprazole oral capsule.

06

What researchers measure

Primary outcomes

  1. 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)

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

  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)

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

Secondary outcomes

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

    plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level

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

  2. Incidence of adverse events [Safety and tolerability]

    Incidence of adverse events

    Time frame: Up to 14 days after the last study drug administration

07

Study locations

1 site
  • Celerion
    Lincoln, Nebraska 68502, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04138836
Lead sponsor
Bridge Biotherapeutics, Inc.
Collaborators
KCRN Research, LLC
Responsible party
Sponsor
First posted
Oct 25, 2019
Start date
Sep 17, 2019
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019
Last update
Jan 18, 2020

Study contacts

Jeong-Hyun Ryou, M.D., Ph.D.
study director · Bridge Biotherapeutics, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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