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OpenTrials
Completed

NCT Number: NCT05181085

Study of NST-6179 in Healthy Subjects

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NST 6179

Drug

orally administered, fully synthetic medium chain fatty acid (MCFA) analogue

Placebo

Drug

inactive analogue

Primary outcomes

  1. Number of Participants With AEs and SAEs Following Administration of NST 6179

    Time frame: From screening to 14 days post final dose, up to 4 weeks.

    Assessment of number of participants with AEs and SAEs to determine safety profile

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of NST 6179

    Time frame: Day 1

    Measure of peak plasma concentration of NST 6179 after dose on Day 1

  2. Peak Plasma Concentration (Cmax) of NST 6179

    Time frame: Day 14

    Measure of peak plasma concentration of NST 6179 after dose on Day 14

Other outcomes

  1. NST 6179 Concentrations and QT Interval

    Time frame: From screening to 14 days post final dose, up to 4 weeks.

    assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected

Sponsors and collaborators

Lead sponsor

NorthSea Therapeutics B.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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