Study of NST-6179 in Healthy Subjects

A Phase 1, First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics 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.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome; Parenteral Nutrition Associated Liver Disease
• Intervention / Treatment: Drug: NST 6179; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical Research Unit, Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NST 6179; double blind, single ascending and multiple ascending dose, sequential group design	Drug: NST 6179; orally administered, fully synthetic medium chain fatty acid (MCFA) analogue
Placebo Comparator: Placebo; matched placebo arm	Drug: Placebo; inactive analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With AEs and SAEs Following Administration of NST 6179	Assessment of number of participants with AEs and SAEs to determine safety profile	From screening to 14 days post final dose, up to 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of NST 6179	Measure of peak plasma concentration of NST 6179 after dose on Day 1	Day 1
Peak Plasma Concentration (Cmax) of NST 6179	Measure of peak plasma concentration of NST 6179 after dose on Day 14	Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NST 6179 Concentrations and QT Interval	assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected	From screening to 14 days post final dose, up to 4 weeks.

Collaborators and Investigators

• Sponsor: NorthSea Therapeutics B.V.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Liver Diseases; Short Bowel Syndrome
• Other Study ID Numbers: NST-6179-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No