A phase I, open-label, single-period, single-dose study to assess the absorption, metabolism, and excretion of oral [14C]NST-6179 (Orziloben) in healthy male subjects

orthSea Therapeutics B.V.0 sites8 target enrollmentJuly 12, 2024

ConditionsIntestinal failure associated liver disease (IFALD), also referred to as parenteral nutrition (PN) associated liver disease, and other potential indications.Digestive System

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Intestinal failure associated liver disease (IFALD), also referred to as parenteral nutrition (PN) associated liver disease, and other potential indications.
Sponsor: orthSea Therapeutics B.V.
Enrollment: 8
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 12, 2024

End Date

August 23, 2024

Last Updated

last year

Study Type

Interventional

Sex

Male

Investigators

Sponsor

orthSea Therapeutics B.V.

Eligibility Criteria

Inclusion Criteria

•1\.Must provide written informed consent.
•2\.Must be willing and able to communicate and participate in the whole study.
•3\.Aged 30 to 65 years inclusive at the time of signing informed consent.
•4\.Must agree to adhere to the contraception requirements defined in the protocol.
•5\.Healthy males according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12\-lead ECG, and clinical laboratory tests without any clinically significant abnormalities.
•6\.Body mass index (BMI) of 18\.0 to 32\.0 kg/m², inclusive, as measured at screening.
•7\.Must have regular bowel movements (i.e. average stool production of \=1 and \=3 stools per day).

Exclusion Criteria

•1\.Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
•2\.Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
•3\.History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator.
•4\.Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
•5\.Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in the protocol). Subjects with Gilbert’s Syndrome are not allowed.
•6\.Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results.
•7\.Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<80 mL/min using the Cockcroft\-Gault equation.
•8\.Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half\-lives prior to Day 1, whichever is longer.
•9\.Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x\-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
•10\.Subjects who have been administered IMP in an ADME study in the last 12 months.