Short Bowel SyndromePhase 1NCT05181085

Study of NST-6179 in Healthy Subjects

A Phase 1 study testing NST 6179 in people with Short Bowel Syndrome and Parenteral Nutrition Associated Liver Disease, run by NorthSea Therapeutics B.V. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
What is being tested?: NST 6179
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteUnited Kingdom
Study dates: 11 Nov 2021to 27 May 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit, Ltd
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: 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.

Conditions: Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
Being tested: NST 6179, Placebo
Medical subject headings: Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NST 6179Drug
orally administered, fully synthetic medium chain fatty acid (MCFA) analogue
PlaceboDrug
inactive analogue

Study groups in NCT05181085
Study group	Role	What they receive
NST 6179	Active comparator	double blind, single ascending and multiple ascending dose, sequential group design Receives: Drug: NST 6179
Placebo	Placebo comparator	matched placebo arm Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Peak Plasma Concentration (Cmax) of NST 6179
Measure of peak plasma concentration of NST 6179 after dose on Day 1
Measured: Day 1
Peak Plasma Concentration (Cmax) of NST 6179
Measure of peak plasma concentration of NST 6179 after dose on Day 14
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202127 May 2022

First posted6 Jan 2022
Study start11 Nov 2021
Primary completion27 May 2022
Study completion27 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05181085
Sponsor's protocol ID: NST-6179-01
Status last verified: Jan 2024
First submitted: 30 Aug 2021
Last updated: 24 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
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Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
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Active, not recruitingObservational study
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All Short Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST 6179 in Healthy Subjects
ClinicalTrials.gov ID: NCT05181085
Acronym / sponsor ID: NST-6179-01
Conditions: Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: NorthSea Therapeutics B.V.Industry (pharma, biotech, devices)
Study start: 11 Nov 2021 (actual)
Primary completion: 27 May 2022 (actual)
Study completion: 27 May 2022 (actual)
First posted: 6 Jan 2022 (actual)
Results: Posted 24 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
NST 6179	Active comparator	Drug: NST 6179double blind, single ascending and multiple ascending dose, sequential group design
Placebo	Placebo comparator	Drug: Placebomatched placebo arm

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

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:
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NST 6179orally administered, fully synthetic medium chain fatty acid (MCFA) analogue	Drug	NST 6179
Placeboinactive analogue	Drug	Placebo

Primary outcome

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

2 secondary outcomes

Peak Plasma Concentration (Cmax) of NST 6179
Time frame: Day 1
Peak Plasma Concentration (Cmax) of NST 6179
Time frame: Day 14

Results and safety

Results posted to the registry on 24 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Dose Placebo	10	10
Single Dose 50 mg NST-6179	6	6
Single Dose 200 mg NST-6179	6	6
Single Dose 400 mg NST-6179	6	6
Single Dose 600 mg NST-6179	6	6
Single Dose 1000 mg NST-6179	6	6
Multiple Dose Placebo	6	6
Multiple Dose 200 mg NST-6179 (QD)	8	8
Multiple Dose 400 mg NST-6179 (QD)	8	8
Multiple Dose 1000 mg NST-6179 (QD)	8	8

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Single Dose Placebo n = 10	Single Dose 50 mg NST-6179 n = 6	Single Dose 200 mg NST-6179 n = 6	Single Dose 400 mg NST-6179 n = 6	Single Dose 600 mg NST-6179 n = 6	Single Dose 1000 mg NST-6179 n = 6	Multiple Dose Placebo n = 6	Multiple Dose 200 mg NST-6179 (QD) n = 8	Multiple Dose 400 mg NST-6179 (QD) n = 8	Multiple Dose 1000 mg NST-6179 (QD) n = 8
Overall TEAEs	4	2	2	2	2	2	2	5	6	5
Serious TEAEs	0	0	0	0	0	0	0	0	0	0
TEAEs leading to discontinuation	0	0	0	0	0	0	0	0	0	0
TEAEs leading to death	0	0	0	0	0	0	0	0	0	0
Mild TEAEs	4	2	2	2	2	1	2	5	5	5
Moderate TEAEs	0	0	0	0	0	1	1	2	3	1
Severe TEAEs	0	0	0	0	0	0	0	0	0	0
Overall treatment-related TEAEs	0	0	0	0	0	1	2	2	5	5

Population analysed: Safety population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening to 14 days post final dose, up to 4 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Dose Placebo	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Single Dose 50 mg NST-6179	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Dose 200 mg NST-6179	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Dose 400 mg NST-6179	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Dose 600 mg NST-6179	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Single Dose 1000 mg NST-6179	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Multiple Dose Placebo	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Multiple Dose 200 mg NST-6179 (QD)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Multiple Dose 400 mg NST-6179 (QD)	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Multiple Dose 1000 mg NST-6179 (QD)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NST 6179 in people with Short Bowel Syndrome and Parenteral Nutrition Associated Liver Disease, run by NorthSea Therapeutics B.V. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.