Clinical trial NCT05181085: Study of NST-6179 in Healthy Subjects
Official title: A Phase 1, First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST 6179 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Short Bowel Syndrome
Parenteral Nutrition Associated Liver Disease
Lead sponsor: NorthSea Therapeutics B.V.
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Males or females, of any race, between 18 and 65 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
3. 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).
4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion Criteria (additional criteria available):

1. 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).
2. 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).
3. Any of the following:

   1. QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 ms confirmed by repeat measurement.
   2. QRS duration \> 110 ms confirmed by repeat measurement.
   3. PR interval \> 220 ms confirmed by repeat measurement.
   4. findings which would make QTc measurements difficult or QTc data uninterpretable.
   5. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
4. 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).
5. 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).
6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
7. Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only).
8. History of alcoholism or drug/chemical abuse within 2 years

Primary outcomes:
measure: Number of Participants With AEs and SAEs Following Administration of NST 6179
timeFrame: From screening to 14 days post final dose, up to 4 weeks.
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of NST 6179
timeFrame: Day 1
measure: Peak Plasma Concentration (Cmax) of NST 6179
timeFrame: Day 14
Other outcomes:
measure: NST 6179 Concentrations and QT Interval
timeFrame: From screening to 14 days post final dose, up to 4 weeks.
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit, Ltd
Study officials:
References: