Phase 1
N=70
Study of NST-6179 in Healthy Subjects
Short Bowel Syndrome · Parenteral Nutrition Associated Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT05181085 ↗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
| Outcome | Result | p-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
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.