Trial · NCT05368831
Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects
NCT05368831, Phase 1, Completed, NorthSea Therapeutics B.V.; results first posted 2024-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects. Trials, record NCT05368831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05368831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects
- NCT number
- NCT05368831
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- NorthSea Therapeutics B.V.
- Conditions
- Healthy Volunteers
- Interventions
- NST-1024
- First posted
- 2022-05-10
- Last updated
- 2024-03-08
- Results first posted
- 2024-03-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 |
| 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 | 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 | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 15 days | PK analysis population | h*ng/mL | GEOMETRIC_MEAN |
| 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 | 15 days | PK analysis population | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects | 15 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Probe Drugs Cocktail #1 | Caffeine | 17100 | Geometric Coefficient of Variation 44.5 | h*ng/mL |
| 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 | 200 mg NST-1024 + Probe Drug Cocktail #1 | Caffeine | 17100 | Geometric Coefficient of Variation 43.4 | h*ng/mL |
| 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 | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Caffeine | 17200 | Geometric Coefficient of Variation 39.1 | h*ng/mL |
| 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 | Probe Drugs Cocktail #1 | Paraxanthine | 10300 | Geometric Coefficient of Variation 29.4 | h*ng/mL |
| 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 | 200 mg NST-1024 + Probe Drug Cocktail #1 | Paraxanthine | 9920 | Geometric Coefficient of Variation 33.9 | h*ng/mL |
| 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 | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Paraxanthine | 10500 | Geometric Coefficient of Variation 35.6 | h*ng/mL |
| 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 | Probe Drugs Cocktail #1 | Midazolam | 35.3 | Geometric Coefficient of Variation 39.5 | h*ng/mL |
| 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 | 200 mg NST-1024 + Probe Drug Cocktail #1 | Midazolam | 37.9 | Geometric Coefficient of Variation 28.2 | h*ng/mL |
| 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 | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | Midazolam | 33.0 | Geometric Coefficient of Variation 43.4 | h*ng/mL |
| 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 | Probe Drugs Cocktail #1 | 1-Hydroxymidazolam | 9.99 | Geometric Coefficient of Variation 44.7 | h*ng/mL |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Probe Drugs Cocktail #1 | STARTED | All Treated Participants | 24 | |
| Probe Drugs Cocktail #1 | COMPLETED | All Treated Participants | 24 | |
| Probe Drugs Cocktail #1 | NOT COMPLETED | All Treated Participants | 0 | |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | STARTED | All Treated Participants | 24 | |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | COMPLETED | All Treated Participants | 24 | |
| 200 mg NST-1024 + Probe Drug Cocktail #1 | NOT COMPLETED | All Treated Participants | 0 | |
| 200 mg NST-1024 (QD) | STARTED | All Treated Participants | 24 | |
| 200 mg NST-1024 (QD) | COMPLETED | All Treated Participants | 21 | |
| 200 mg NST-1024 (QD) | NOT COMPLETED | All Treated Participants | 3 | |
| 200 mg NST-1024 (QD) + Probe Cocktail #2 | STARTED | All Treated Participants | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Probe Drugs Cocktail #1 | 1 | 24 | |
| other | Dizziness | Nervous system disorders | 200 mg NST-1024 + Probe Drug Cocktail #1 | 2 | 24 | |
| other | Dizziness | Nervous system disorders | 200 mg NST-1024 (QD) | 0 | 24 | |
| other | Dizziness | Nervous system disorders | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | 1 | 21 | |
| other | Headache | Nervous system disorders | Probe Drugs Cocktail #1 | 0 | 24 | |
| other | Headache | Nervous system disorders | 200 mg NST-1024 + Probe Drug Cocktail #1 | 0 | 24 | |
| other | Headache | Nervous system disorders | 200 mg NST-1024 (QD) | 1 | 24 | |
| other | Headache | Nervous system disorders | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | 2 | 21 | |
| other | Somnolence | Nervous system disorders | Probe Drugs Cocktail #1 | 0 | 24 | |
| other | Somnolence | Nervous system disorders | 200 mg NST-1024 + Probe Drug Cocktail #1 | 1 | 24 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Probe Drugs Cocktail #1 | 0 | 24 |
| Total, all-cause mortality | 200 mg NST-1024 + Probe Drug Cocktail #1 | 0 | 24 |
| Total, all-cause mortality | 200 mg NST-1024 (QD) | 0 | 24 |
| Total, all-cause mortality | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | 0 | 21 |
| Total, other adverse events | Probe Drugs Cocktail #1 | 6 | 24 |
| Total, other adverse events | 200 mg NST-1024 + Probe Drug Cocktail #1 | 6 | 24 |
| Total, other adverse events | 200 mg NST-1024 (QD) | 9 | 24 |
| Total, other adverse events | 200 mg NST-1024 (QD) + Probe Drugs Cocktail #2 | 8 | 21 |
| Total, serious adverse events | Probe Drugs Cocktail #1 | 0 | 24 |
| Total, serious adverse events | 200 mg NST-1024 + Probe Drug Cocktail #1 | 0 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05368831
GET https://conductscience.org/api/trials/v1/NCT05368831/results?page=2