Study of NST-6179 in Healthy Subjects

NCT05181085 | Completed Phase 1 Results DMC

• 1 other identifier: NST-6179-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome; Parenteral Nutrition Associated Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Peak Plasma Concentration (Cmax) of NST 6179

  Day 1

• Peak Plasma Concentration (Cmax) of NST 6179

  Day 14

Other Outcomes (1)

• NST 6179 Concentrations and QT Interval

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

Study Arms (2)

NST 6179

ACTIVE COMPARATOR

double blind, single ascending and multiple ascending dose, sequential group design

Drug: NST 6179

Placebo

PLACEBO COMPARATOR

matched placebo arm

Drug: Placebo

Interventions

NST 6179 DRUG

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

NST 6179

Placebo DRUG

inactive analogue

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NorthSea Therapeutics B.V.: lead

Study Sites (1)

Covance Clinical Research Unit, Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Yokley
• Organization: NorthSea Therapeutics BV

info@northseatherapeutics.com

31 035760 65 05

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: January 6, 2022
• Study Start: November 11, 2021
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-01

Locations

GB (1)