Trial · NCT07884734
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUClast of Radiprodil - Part A | Part A: Day 1 through Day 19 | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUClast) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. |
| Primary | AUCinf of Radiprodil - Part A | Part A: Day 1 through Day 19 | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. |
| Primary | Cmax of Radiprodil - Part A | Part A: Day 1 through Day 19 | Maximum observed plasma concentration (Cmax) of radiprodil following administration of radiprodil alone on Day 1 and with carbamazepine on Day 16. The effect of carbamazepine will be assessed using the geometric mean ratio and 90% confidence interval. |
| Primary | AUClast of Radiprodil - Part B | Part B: Day 1 through Day 12 | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUClast) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval. |
| Primary | AUCinf of Radiprodil - Part B | Part B: Day 1 through Day 12 | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval. |
| Primary | Cmax of Radiprodil - Part B | Part B: Day 1 through Day 12 | Maximum observed plasma concentration (Cmax) of radiprodil following administration of radiprodil alone on Day 1 and with itraconazole on Day 9. The effect of itraconazole will be assessed using the geometric mean ratio and 90% confidence interval. |
| Secondary | AUClast of Carbamazepine - Part A | Part A: Day 16 (up to 12 hours post-dose) | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of carbamazepine following administration alone and in combination with radiprodil. |
| Secondary | AUCtau of Carbamazepine - Part A | Part A: Day 16 (up to 12 hours post-dose) | Area under the plasma concentration-time curve over the 12-hour dosing interval (AUCtau) of carbamazepine following coadministration with radiprodil. |
| Secondary | Cmax of Carbamazepine - Part A | Part A: Day 16 (up to 12 hours post-dose) | Maximum observed plasma concentration (Cmax) of carbamazepine following coadministration with radiprodil. |
| Secondary | Tmax of Carbamazepine - Part A | Part A: Day 16 (up to 12 hours post-dose) | Time to reach maximum observed plasma concentration of carbamazepine following administration alone and in combination with radiprodil. |
| Secondary | AUClast of Itraconazole - Part B | Part B: Day 9 through Day 10 (up to 24 hours post-dose) | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of itraconazole following administration alone and in combination with radiprodil. |
| Secondary | AUCtau of Itraconazole - Part B | Part B: Day 9 through Day 10 (up to 24 hours post-dose) | Area under the plasma concentration-time curve over the dosing interval of itraconazole following administration alone and in combination with radiprodil. |
| Secondary | Cmax of Itraconazole - Part B | Part B: Day 9 through Day 10 (up to 24 hours post-dose) | Maximum observed plasma concentration of itraconazole following administration alone and in combination with radiprodil. |
| Secondary | Tmax of Itraconazole - Part B | Part B: Day 9 through Day 10 (up to 24 hours post-dose) | Time to reach maximum observed plasma concentration of itraconazole following administration alone and in combination with radiprodil. |
| Secondary | Tmax of Radiprodil - Part A | Part A: Day 1 through Day 19 | Time to reach maximum observed plasma concentration of radiprodil. Assessed following administration of radiprodil alone and in combination with carbamazepine. |
| Secondary | Terminal Elimination Half-Life (t½) of Radiprodil - Part A | Part A: Day 1 through Day 19 | Terminal elimination half-life of radiprodil, defined as the time required for plasma concentration to decrease by half during the terminal elimination phase. Assessed following administration of radiprodil alone and in combination with carbamazepine. |
| Secondary | Apparent Total Body Clearance (CL/F) of Radiprodil - Part A | Part A: Day 1 through Day 19 | Apparent total body clearance of radiprodil following oral administration. Assessed following administration of radiprodil alone and in combination with carbamazepine. |
| Secondary | Apparent Volume of Distribution (Vz/F) of Radiprodil - Part A | Part A: Day 1 through Day 19 | Apparent volume of distribution of radiprodil during the terminal elimination phase following oral administration. Assessed following administration of radiprodil alone and in combination with carbamazepine. |
| Secondary | Tmax of Radiprodil - Part B | Part B: Day 1 through Day 12 | Time to reach maximum observed plasma concentration of radiprodil. Assessed following administration of radiprodil alone and in combination with itraconazole. |
| Secondary | Terminal Elimination Half-Life (t½) of Radiprodil - Part B | Part B: Day 1 through Day 12 | Terminal elimination half-life of radiprodil, defined as the time required for plasma concentration to decrease by half during the terminal elimination phase. Assessed following administration of radiprodil alone and in combination with itraconazole. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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