- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05181085
Study of NST-6179 in Healthy Subjects
December 1, 2022 updated by: NorthSea Therapeutics B.V.
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leeds, United Kingdom, LS2 9LH
- Covance Clinical Research Unit, Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: NST 6179
double blind, single ascending and multiple ascending dose, sequential group design
|
orally administered, fully synthetic medium chain fatty acid (MCFA) analogue
|
PLACEBO_COMPARATOR: Placebo
matched placebo arm
|
inactive analogue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assess AEs and SAEs to determine safety profile of single and multiple doses of NST 6179
Time Frame: 12 weeks
|
assess AEs and SAEs to determine safety profile
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
single and multiple dose PK of NST 6179
Time Frame: 12 weeks
|
measure of peak plasma concentration of subjects after dose
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NST 6179 concentrations and QT interval
Time Frame: 12 weeks
|
assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 7, 2021
Primary Completion (ACTUAL)
May 30, 2022
Study Completion (ACTUAL)
May 30, 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)
December 2, 2022
Last Update Submitted That Met QC Criteria
December 1, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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