Healthy Volunteers
Conditions
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.
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 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.
Interventions
DRUGNST-1024
Drug Drug interactions between NST-1024 and caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam
Sponsors
NorthSea Therapeutics B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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, 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). 4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4. 5. Able to comprehend and willing to sign an Informed Consent Form (ICF) and to abide by the study restrictions
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 15 days | 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 |
| Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | 15 days | Evaluate the effects of NST-1024 on the PK (Cmax) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | 15 days | Assess AEs and SAEs to support ongoing safety profile data |
Countries
United Kingdom
Participant flow
Pre-assignment details
Following screening, eligible participants were to receive each of the following treatments: * Day 1: Probe Drugs Cocktail #1 * Day 8: 200 mg NST-1024 + Probe Drug Cocktail #1 * Days 8 to 22: 200 mg NST-1024 once daily * Day 21: 200 mg NST-1024 + Probe Drug Cocktail #2
Participants by arm
| Arm | Count |
|---|---|
| All Treated Participants * 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 200 mg NST-1024 (QD) | Adverse Event | 3 |
Baseline characteristics
| Characteristic | All Treated Participants |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 15.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United Kingdom | 24 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 6 / 24 | 6 / 24 | 9 / 24 | 8 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 21 |
Outcome results
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
Time frame: 15 days
Population: PK analysis population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Probe Drugs Cocktail #1 | 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 | Caffeine | 17100 h*ng/mL | Geometric Coefficient of Variation 44.5 |
| Probe Drugs Cocktail #1 | 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 | Paraxanthine | 10300 h*ng/mL | Geometric Coefficient of Variation 29.4 |
| Probe Drugs Cocktail #1 | 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 | Midazolam | 35.3 h*ng/mL | Geometric Coefficient of Variation 39.5 |
| Probe Drugs Cocktail #1 | 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 | 1-Hydroxymidazolam | 9.99 h*ng/mL | Geometric Coefficient of Variation 44.7 |
| Probe Drugs Cocktail #1 | 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 | Flurbiprofen | 37600 h*ng/mL | Geometric Coefficient of Variation 27.3 |
| Probe Drugs Cocktail #1 | 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 | Metoprolol | 654 h*ng/mL | Geometric Coefficient of Variation 89 |
| Probe Drugs Cocktail #1 | 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 | Omeprazole | 428 h*ng/mL | Geometric Coefficient of Variation 120.8 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Flurbiprofen | 34500 h*ng/mL | Geometric Coefficient of Variation 29.4 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Caffeine | 17100 h*ng/mL | Geometric Coefficient of Variation 43.4 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Metoprolol | 745 h*ng/mL | Geometric Coefficient of Variation 75 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Paraxanthine | 9920 h*ng/mL | Geometric Coefficient of Variation 33.9 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Midazolam | 37.9 h*ng/mL | Geometric Coefficient of Variation 28.2 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | Omeprazole | 432 h*ng/mL | Geometric Coefficient of Variation 140.9 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | 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 | 1-Hydroxymidazolam | 10.3 h*ng/mL | Geometric Coefficient of Variation 50.4 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #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 | Midazolam | 33.0 h*ng/mL | Geometric Coefficient of Variation 43.4 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #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 | Paraxanthine | 10500 h*ng/mL | Geometric Coefficient of Variation 35.6 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #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 | Caffeine | 17200 h*ng/mL | Geometric Coefficient of Variation 39.1 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #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 | 1-Hydroxymidazolam | 11.6 h*ng/mL | Geometric Coefficient of Variation 24.7 |
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
Time frame: 15 days
Population: PK analysis population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Caffeine | 2390 ng/mL | Geometric Coefficient of Variation 21.9 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Paraxanthine | 656 ng/mL | Geometric Coefficient of Variation 18.8 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Midazolam | 12.8 ng/mL | Geometric Coefficient of Variation 26.8 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | 1-Hydroxymidazolam | 4.14 ng/mL | Geometric Coefficient of Variation 46.7 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Flurbiprofen | 7240 ng/mL | Geometric Coefficient of Variation 32.9 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Metoprolol | 127 ng/mL | Geometric Coefficient of Variation 53 |
| Probe Drugs Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Omeprazole | 221 ng/mL | Geometric Coefficient of Variation 86.9 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Flurbiprofen | 6480 ng/mL | Geometric Coefficient of Variation 36.4 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Caffeine | 2390 ng/mL | Geometric Coefficient of Variation 26.4 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Metoprolol | 142 ng/mL | Geometric Coefficient of Variation 58.6 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Paraxanthine | 630 ng/mL | Geometric Coefficient of Variation 17.5 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Midazolam | 12.8 ng/mL | Geometric Coefficient of Variation 24.7 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Omeprazole | 189 ng/mL | Geometric Coefficient of Variation 115.5 |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | 1-Hydroxymidazolam | 3.69 ng/mL | Geometric Coefficient of Variation 63.5 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Midazolam | 12.1 ng/mL | Geometric Coefficient of Variation 35 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Paraxanthine | 617 ng/mL | Geometric Coefficient of Variation 20.4 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | Caffeine | 2330 ng/mL | Geometric Coefficient of Variation 25.4 |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects | 1-Hydroxymidazolam | 4.54 ng/mL | Geometric Coefficient of Variation 37.1 |
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
Time frame: 15 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Moderate | 0 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Mild | 6 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to death | 0 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Overall | 6 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Severe | 0 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Serious | 0 participants |
| Probe Drugs Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to discontinuation | 0 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Mild | 6 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to discontinuation | 0 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Serious | 0 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to death | 0 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Moderate | 0 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Overall | 6 participants |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Severe | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to discontinuation | 3 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Moderate | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Overall | 9 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Serious | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to death | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Mild | 9 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Severe | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Serious | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Severe | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Moderate | 2 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Overall | 8 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Severity - Mild | 7 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to death | 0 participants |
| 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | Leading to discontinuation | 0 participants |