Status:
COMPLETED
Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects
Lead Sponsor:
NorthSea Therapeutics B.V.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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) ...
Detailed Description
Up to 21 subjects will be enroled to ensure that 18 subjects complete the study. All subjects will receive each of the following treatments: * Day 1: single oral dose of 100 mg caffeine, 50 mg flurbi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05368831
Start Date
July 19 2022
End Date
September 7 2022
Last Update
March 8 2024
Active Locations (1)
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1
Labcorp Clinical Research Unit Ltd.
Leeds, United Kingdom