Study of NST-6179 in Healthy Subjects

Sponsor

NorthSea Therapeutics B.V. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05181085

Collaborator

(none)

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome Parenteral Nutrition Associated Liver Disease	Drug: NST 6179 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

assess AEs and SAEs to determine safety profile of single and multiple doses of NST 6179 [12 weeks]
assess AEs and SAEs to determine safety profile

Secondary Outcome Measures

single and multiple dose PK of NST 6179 [12 weeks]
measure of peak plasma concentration of subjects after dose

Other Outcome Measures

NST 6179 concentrations and QT interval [12 weeks]
assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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/m2, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit, Ltd	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

NorthSea Therapeutics B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NorthSea Therapeutics B.V.

ClinicalTrials.gov Identifier:

NCT05181085

Other Study ID Numbers:

NST-6179-01

First Posted:

Jan 6, 2022

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Short Bowel Syndrome

Study Results

No Results Posted as of May 9, 2022