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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004921-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
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The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.
The aim of the study is to develop a modified release oral tablet formulation that maintains plasma concentrations within the target therapeutic range, and is safe and tolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTL0009936 modified release (MR) Formulation | Experimental | Intervention: 5 different modified release formulations of HTL0009936, as a single dose |
|
| HTL00009936 immediate release (IR) fasted | Active Comparator | Intervention: 1 immediate release formulation of HTL0009936, as a single dose in the fasted state |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTL0009936 modified release | Drug | HTL0009936 modified release |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tlag | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the elapsed time from dosing at which HTL0009936 was first quantifiable in a concentration vs time profile (Tlag). | 14 weeks |
| Frel | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of relative bioavailability (Frel) of HTL0009936 MR prototype formulations compared to the IR reference formulation and, if applicable, MR prototype formulations in the fed state compared to fasted state. | 14 weeks |
| Tmax | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the elapsed time from dosing at which the maximum observed HTL0009936 concentration (Cmax) was apparent (Tmax) | 14 weeks |
| Cmax | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of Cmax. | 14 weeks |
| Concentration of HTL0009936 at 6 hours post dose (C6) | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of HTL0009936 concentration at 6 hours post-dose (C6) | 6 hours post dose |
| AUC (0-last) | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the area under the concentration versus time curve from time zero to the last measurable concentration (AUC(0-last)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Litza McKenzie, MBChB | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| HTL0009936 immediate release | Drug | HTL0009936 immediate release |
|
| 14 weeks |
| AUC (0-inf) | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the area under the concentration versus time curve from time zero to extrapolated to infinity (AUC(0-inf)). | 14 weeks |
| AUC%extrap | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of percentage of AUC(0-inf) extrapolated beyond last measured time point (AUC%extrap). | 14 weeks |
| Lambda-z | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the slope of the apparent elimination phase (Lambda-z). | 14 weeks |
| T1/2 | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of the apparent elimination half-life (T1/2). | 14 weeks |
| Dose normalized AUC | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. In addition, if different dose levels of the same prototype are administered, dose normalized AUC (AUC/D) will be calculated. | 14 weeks |
| Dose normalized Cmax | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. In addition, if different dose levels of the same prototype are administered, dose normalized Cmax (Cmax/D) will be calculated. | 14 weeks |
| Concentration of HTL0009936 at 12 hours post dose (C12) | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of HTL0009936 concentration at 12 hours post-dose (C12) | 12 hours post dose |
| Concentration of HTL0009936 at 24 hours post dose (C24) | The PK profiles of HTL0009936 Modified release oral prototype formulations in healthy CYP2D6 IM and EM subjects. Calculation of HTL0009936 concentration at 24 hours post-dose (C24) | 24 hours post dose |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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