A Phase 1, First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST 6179 in Healthy Subjects

NorthSea Therapeutics B.V.1 site in 1 country70 target enrollmentNovember 11, 2021

ConditionsShort Bowel Syndrome Parenteral Nutrition Associated Liver Disease

InterventionsNST 6179 Placebo

Overview

Phase: Phase 1
Intervention: NST 6179
Conditions: Short Bowel Syndrome
Sponsor: NorthSea Therapeutics B.V.
Enrollment: 70
Locations: 1
Primary Endpoint: Number of Participants With AEs and SAEs Following Administration of NST 6179
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.

Registry

clinicaltrials.gov

Start Date

November 11, 2021

End Date

May 27, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

NorthSea Therapeutics B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females, of any race, between 18 and 65 years of age, inclusive.
•Body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
•In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and/or check in as assessed by the investigator (or designee).
•Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
•Able to comprehend and willing to sign an ICF and to abide by the study restrictions
•Exclusion Criteria (additional criteria available):
•Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
•History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
•Any of the following:
•QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 ms confirmed by repeat measurement.