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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001613-53 | EudraCT Number |
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The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MIN-101 | Experimental | MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg |
|
| Part 2: MIN-101 low dose | Experimental | MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
|
| Part 2: placebo | Placebo Comparator | placebo MIN-101 daily oral dose from Day 1 to Day 7 |
|
| Part 2: MIN-101 high dose | Experimental | MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIN-101 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio | predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose | |
| Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF) | predose to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) - | from predose up to 72 h post dosing | |
| Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state | from predose up to 72 h post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep architecture and sleep continuity | Day 6 |
Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pui Leung, M.D | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington, Nottingham | NG116JS | United Kingdom |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000625557 | roluperidone |
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| Drug |
|
| Part 2 Change from baseline in ECG parameters other than QT/QTc | QTcB, QRS, RR, PR intervals, U waves, T waves morphology | from predose up to Day 8 |
| Part 2 Change from baseline in heart rate and blood pressure | from predose up to Day 8 |
| Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose | from predose up to Day 8 |
| Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose | from predose up to Day 8 |
| Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests) | from predose up to Day 8 |