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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138836
• Other study ID #: BBT877-IPF-002
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: January 2020
• Source: Bridge Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BBT-877
BBT-877 oral capsule.
• Midazolam
Midazolam oral syrup.
• Itraconazole
Itraconazole oral capsule.
• Esomeprazole
Esomeprazole oral capsule.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Bridge Biotherapeutics, Inc.	KCRN Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Day 1 of period 1 and Day 10 (Arm 1), 5 (Arm 2), or 5 (Arm 3) of period 2
Secondary	Incidence of adverse events [Safety and tolerability]	Incidence of adverse events	Up to 14 days after the last study drug administration