Study of NST-6179 in Healthy Subjects

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181085
• Other study ID #: NST-6179-01
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: December 2022
• Source: NorthSea Therapeutics B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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/m2, 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

Related Conditions & MeSH terms

• Liver Diseases
• Parenteral Nutrition Associated Liver Disease
• Short Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit, Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
NorthSea Therapeutics B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NST 6179 concentrations and QT interval	assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected	12 weeks
Primary	assess AEs and SAEs to determine safety profile of single and multiple doses of NST 6179	assess AEs and SAEs to determine safety profile	12 weeks
Secondary	single and multiple dose PK of NST 6179	measure of peak plasma concentration of subjects after dose	12 weeks