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This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data.
Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.
Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTD-001 (fed) | Experimental |
| |
| BTD-001 (fasted) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTD-001 | Drug | BTD-001 in fed vs fasted state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 & Part 2 - Cmax of BTD-001 and major metabolites | Maximum Observed Plasma Concentration | [Maximum 30 days] |
| Part 1 & Part 2 - Tmax of BTD-001 and major metabolites | Time to Maximum Observed Plasma Concentration | [Maximum 30 days] |
| Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites | Area Under the Curve for Observed Plasma Concentration | [Maximum 30 days] |
| Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites | elimination half-life | [Maximum 30 days] |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Examination | Safety and tolerability of BTD-001 by assessing physical examination | [Maximum 30 days] |
| Vital Signs | Safety and tolerability of BTD-001 by assessing vital signs |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale | To assess sleepiness using the KSS | [Maximum 30 days] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nand Signh, MD | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| [Maximum 30 days] |
| ECG | Safety and tolerability of BTD-001 by assessing ECG | [Maximum 30 days] |
| Adverse Events | Safety and tolerability of BTD-001 by assessing AEs | [Maximum 30 days] |
| Safety Lab Test | Safety and tolerability of BTD-001 by assessing safety lab tests | [Maximum 30 days] |
| Likert Scales | To assess BTD-001 withdrawal in healthy volunteers | [Maximum 30 days] |