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Trial record 2 of 3 for:    bbt877

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138836
Recruitment Status : Completed
First Posted : October 25, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
KCRN Research, LLC
Information provided by (Responsible Party):
Bridge Biotherapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BBT-877 Drug: Midazolam Drug: Itraconazole Drug: Esomeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-Part, Phase 1 Study to Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects
Actual Study Start Date : September 17, 2019
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Midazolam Drug: BBT-877
BBT-877 oral capsule.

Drug: Midazolam
Midazolam oral syrup.

Experimental: Itraconazole Drug: BBT-877
BBT-877 oral capsule.

Drug: Itraconazole
Itraconazole oral capsule.

Experimental: Esomeprazole Drug: BBT-877
BBT-877 oral capsule.

Drug: Esomeprazole
Esomeprazole oral capsule.




Primary Outcome Measures :
  1. AUC (the area under the curve) [Pharmacokinetics] [ Time Frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 ]
    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)

  2. Cmax (peak concentration) [Pharmacokinetics] [ Time Frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 ]
    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)


Secondary Outcome Measures :
  1. Plasma LPA (Lysophosphatidic acid) concentration [Pharmacodynamics (Arm 2 and 3)] [ Time Frame: Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2 ]
    plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level

  2. Incidence of adverse events [Safety and tolerability] [ Time Frame: Up to 14 days after the last study drug administration ]
    Incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138836


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Bridge Biotherapeutics, Inc.
KCRN Research, LLC
Investigators
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Study Director: Jeong-Hyun Ryou, M.D., Ph.D. Bridge Biotherapeutics, Inc.

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Responsible Party: Bridge Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04138836    
Other Study ID Numbers: BBT877-IPF-002
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Midazolam
Esomeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors