A Phase 1 Drug-Drug Interaction Study to Assess the Interaction Potential of NB-4746 on CYP1A2 and CYP3A4 Substrates in Healthy Volunteers

ura Bio0 sites18 target enrollmentSeptember 5, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ura Bio
Enrollment: 18
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 5, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

ura Bio

Eligibility Criteria

Inclusion Criteria

•Participants will be eligible to be included in the study if all of the following criteria apply:
•1\.Aged greater or equal to 18 years and less than or equal to 65 years.
•2\.Body mass index (BMI) within the range 18 to 30 kg per m2 (inclusive).
•3\.Overtly healthy, as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (ECG) obtained at screening and Day 1\.
•4\.Baseline (screening and Day \-1\) laboratory test values within normal ranges. Out of normal range values may be accepted by the Investigator, if not clinically significant, with the exception of the following:
•a.Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 1\.5 x upper limit of normal.
•b.Total, indirect, or direct bilirubin greater than 1\.5 x upper limit of normal. Participants with Gilbert’s syndrome with indirect bilirubin outside of the normal range will be excluded from the study.
•c.Creatinine clearance less than 80 mL per min (estimated from Cockcroft Gault equation).
•d.Amylase and lipase must be within the normal range at screening and Day \-1\.
•5\.Nonsmoker and or ex\-smoker who has discontinued smoking and or use of nicotine\-containing products (including nicotine and non\-nicotine vapes) for at least 3 months prior to the first dose of study drug, confirmed by a negative carbon monoxide (CO) breath test at screening and Day \-1\.

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1\.History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs; or interfering with the interpretation of data.
•2\.History of pancreatitis or with prior cholecystectomy.
•3\.Any history of significant medical illness or any chronic medical illness, as determined by the investigator.
•4\.Mentally or legally incapacitated, has significant emotional problems at screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: normal healthy volunteers who have had situational depression may be enrolled in the study at the discretion of the Investigator.
•5\.History of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
•6\.Has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.
•7\.Has donated more than 1 unit (500 mL) of blood within 4 weeks prior to the first dose of study drug.
•8\.Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
•9\.Abnormal heart rate or blood pressure (mean resting heart rate less than or equal to 40 or greater than or equal to 100 bpm, systolic BP less than or equal to 90 or greter than or equal to 149 mmHg, diastolic BP less than or equal to 50 to greater than or equal to 90 mmHg) at screening or before the first administration of study drug. Vitals may be repeated up to 2 times for the purpose of eligibility.