Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Up to 21 subjects will be enroled to ensure that 18 subjects complete the study. All subjects will receive each of the following treatments:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NST-1024 | Drug | Drug Drug interactions between NST-1024 and caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Assess AEs and SAEs to support ongoing safety profile data | 15 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Ltd. | Leeds | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Following screening, eligible participants were to receive each of the following treatments:
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Treated Participants | All participants received each of the following treatments:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Probe Drugs Cocktail #1 |
| |||||||||||||
| 200 mg NST-1024 + Probe Drug Cocktail #1 |
| |||||||||||||
| 200 mg NST-1024 (QD) |
| |||||||||||||
| 200 mg NST-1024 (QD) + Probe Cocktail #2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Treated Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | PK analysis population | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 15 days |
|
From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Probe Drugs Cocktail #1 | Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam on day 1. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CLIENT TO PROVIDE | NorthSea Therapeutics BV | 31 035760 65 05 | info@northseatherapeutics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2022 | Apr 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2022 | Apr 27, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 |
Participants received a 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 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state. |
| OG002 | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state. |
|
|
| Primary | 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 | PK analysis population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 15 days |
|
|
|
| Secondary | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Assess AEs and SAEs to support ongoing safety profile data | Posted | Number | participants | 15 days |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | 200 mg NST-1024 + Probe Drug Cocktail #1 | Participants received a 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 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state. | 0 | 24 | 0 | 24 | 6 | 24 |
| EG002 | 200 mg NST-1024 (QD) | Participants received oral doses of 200 mg NST-1024 on study days 8-22. Each dose was administered with approximately 240 mL of room temperature water | 0 | 24 | 0 | 24 | 9 | 24 |
| EG003 | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state. | 0 | 21 | 0 | 21 | 8 | 21 |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Paraxanthine |
|
|
| Midazolam |
|
|
| 1-Hydroxymidazolam |
|
|
| Flurbiprofen |
|
|
| Metoprolol |
|
|
| Omeprazole |
|
|
| Serious |
|
| Leading to discontinuation |
|
| Leading to death |
|
| Severity - Mild |
|
| Severity - Moderate |
|
| Severity - Severe |
|