Trial · NCT06643637
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs) | Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23) | Physical examinations, safety laboratory tests, ECGs |
| Primary | Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS). | Screening (Day -28) to end of study visit (Cohort 1: Day 15; Cohort 2: Day 23) | The Columbia Suicide Severity Rating Scale (C-SSRS) is a short questionnaire. If there is a positive result for suicidality on the C-SSRS after Screening (defined by a participant answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS), the participant will be evaluated by an Investigator or medically qualified Sub-investigator for continuation in the study. Participants with suicidal ideation or behaviour (a "yes" answer at any time during treatment to any one of the ten suicidal ideation and behaviour questions (Categories 1-10) on the C-SSRS) at any time during the study will be withdrawn from the study. If a participant becomes suicidal during the study, an Investigator or medically qualified Sub-investigator should provide the appropriate treatment to the participant. |
| Secondary | Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Pharmacokinetics of MLS101: area under the plasma concentration-time curve (AUC) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (Tmax) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F) | Day 1 to Day 8 pre-dose, Day 1 to Day 9 post-dose (Cohort 1); Day 1 to Day 16 pre-dose, Day 1 to Day 17 post-dose (Cohort 2) | Blood sample collections |
| Secondary | Sensorial effects of MLS101 | Day 1 to Day 8 pre- and post-dose (Cohort 1); Day 1 to Day 16 pre- and post-dose (Cohort 2) | Using validated questionnaires, the nominal sensorial threshold dose of MLS101 will be identified. The nominal sensorial threshold dose is defined as the highest dose studied that is absent of clinically significant sensorial effects, and which would not interfere with the participant's ability to carry on with routine activities of daily living. Higher scores indicate presence of sensorial effects. |
| Secondary | Cognitive function: Digit Symbol Substitution Test (DSST) | Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2) | The test taker's score is the number of correct symbol-to-number matches they complete within the allotted time. |
| Secondary | Cognitive Function: Stroop Color and Word Test (SCWT) | Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2) | Participants read tables of words and colors as quickly as possible. |
| Secondary | Cognitive function: Trail Making Test A (TMT-A) | Pre-dose (Day -1), Day 1, Day 4 and Day 8 (Cohort 1); Pre-dose (Day -1), Day 1, Day 4 and Day 16 (Cohort 2) | The participant draws lines to connect circled numbers in an ascending pattern (i.e., in numerical sequence 1-2-3, etc.) as rapidly as possible. The score is the time it takes the participant to complete the task in seconds. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06643637/registered