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Phase 1 N=70 Randomized Triple-blind Treatment

Study of NST-6179 in Healthy Subjects

Short Bowel Syndrome · Parenteral Nutrition Associated Liver Disease

Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With AEs and SAEs Following Administration of NST 6179 — 4; 2; 2; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
NST 6179 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
NorthSea Therapeutics B.V.
Primary completion
May 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With AEs and SAEs Following Administration of NST 6179
4; 2; 2; 2; 2; 2
SECONDARY
Peak Plasma Concentration (Cmax) of NST 6179
6920; 10000; 31800
SECONDARY
Peak Plasma Concentration (Cmax) of NST 6179
6920; 10000; 31800

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.

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.
  • QRS duration > 110 ms confirmed by repeat measurement.
  • PR interval > 220 ms confirmed by repeat measurement.
  • findings which would make QTc measurements difficult or QTc data uninterpretable.
  • history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
  • Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee).
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
  • Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only).
  • History of alcoholism or drug/chemical abuse within 2 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05181085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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