Trial · NCT06107803
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 39
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extrapyramidal Symptoms Assessed by Abnormal Involuntary Movement Scale (AIMS) - Change From Baseline in AIMS Component Movement | Overall Safety Set | 0.0 | Standard Deviation 0.00 | score on a scale | |
| Barnes Akathisia Rating Scale (BARS) | Overall Safety Set | 0.0 | Standard Deviation 0.00 | score on a scale | |
| Number of Subjects Who Experienced Suicidal Ideation or Behavior Events Per the Columbia Suicide Severity Rating Scale (C-SSRS) | Overall Safety Set | 0 | Participants | ||
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 1 | 32.5 | Standard Deviation 13.7 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 1 | 5.00 | Standard Deviation 5.69 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 7 | 43.6 | Standard Deviation 19.9 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 7 | 7.98 | Standard Deviation 6.78 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Roluperidone | Treatment Phase 2 - Day 17 | 67.7 | Standard Deviation 28.6 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Maximum Plasma Concentration (Cmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 2 - Day 17 | 12.2 | Standard Deviation 12.9 | ng/ml |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 1 | 9.74 | Standard Deviation 7.37 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 1 | 16.2 | Standard Deviation 6.72 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 7 | 7.47 | Standard Deviation 5.73 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 7 | 9.60 | Standard Deviation 6.02 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Roluperidone | Treatment Phase 2 - Day 17 | 6.20 | Standard Deviation 4.56 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Time to Maximum Plasma Concentration (Tmax) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 2 - Day 17 | 8.76 | Standard Deviation 4.90 | hr |
| Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 1 | 391 | Standard Deviation 252 | hr*ng/mL |
| Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 1 | 52.3 | Standard Deviation 63.0 | hr*ng/mL |
| Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Overall Safety Set - Roluperidone | Treatment Phase 1 - Day 7 | 507 | Standard Deviation 278 | hr*ng/mL |
| Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Overall Safety Set - Metabolite BFB-520 | Treatment Phase 1 - Day 7 | 135 | Standard Deviation 122 | hr*ng/mL |
| Pharmacokinetic Evaluation of Roluperidone - Area Under the Plasma Concentration Versus Time Curve (AUC 0-24) | Overall Safety Set - Roluperidone | Treatment Phase 2 - Day 17 | 720 | Standard Deviation 321 | hr*ng/mL |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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