Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects

NCT05368831 | Completed Phase 1 Results

• 1 other identifier: NST-1024-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1, open label study to evaluate the effects of NST-1024 on the pharmacokinetics (PK) of caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam (and 1-hydroxymidazolam) in healthy male and female subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects

  Evaluate the effects of NST-1024 on the pharmacokinetics (PK) (AUC0-t) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects

  15 days

• Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects

  Evaluate the effects of NST-1024 on the PK (Cmax) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects

  15 days

Secondary Outcomes (1)

• Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects

  15 days

Study Arms (1)

Oral dose of NST-1024, Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam

EXPERIMENTAL

Day 1: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam * Days 8 to 22: oral doses of 200 mg NST-1024 qd multiple-dose regimen * Day 8: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 * Day 21: single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024.

Drug: NST-1024

Interventions

NST-1024 DRUG

Drug Drug interactions between NST-1024 and caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam

Oral dose of NST-1024, Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam

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/m2, inclusive.
• In good health, determined by no clinically significant findings from medical history, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and/or check in and from the physical examination at 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 as detailed in Appendix 4.
• Able to comprehend and willing to sign an Informed Consent Form (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 (CV), gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• History of febrile illness within 1 week prior to the first dose.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved 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).
• Confirmed (eg, 2 consecutive measurements) systolic blood pressure \>160 or \<80 mmHg, diastolic blood pressure \>90 or \<45 mmHg, and pulse rate \>100 or \<40 beats per minute.
• Positive hepatitis panel and/or positive human immunodeficiency virus test
• Administration of a coronavirus disease 2019 vaccine in the past 30 days prior to dosing.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including over-the-counter and herbal medication, 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.
• Alcohol consumption of \>21 units (males) and \>14 units (females) per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Receipt of blood products within 2 months prior to check in.

Sponsors & Collaborators

• NorthSea Therapeutics B.V.: lead

Study Sites (1)

Labcorp Clinical Research Unit Ltd.

Leeds, United Kingdom

Location

Results Point of Contact

• Title: CLIENT TO PROVIDE
• Organization: NorthSea Therapeutics BV

info@northseatherapeutics.com

31 035760 65 05

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 10, 2022
• Study Start: July 19, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)