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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003313-99 | EudraCT Number | ||
| 16-024 | Other Identifier | HMR Protocol Code |
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HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label, randomised, crossover, single dose, trial in healthy volunteers to compare the relative bioavailability of HTL0018318 when given by oral aqueous solution and in capsule formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTL0018318 low dose | Active Comparator | low dose aqueous solution and/or equivalent low dose capsule |
|
| HTL0018318 mid dose | Active Comparator | mid dose aqueous solution and/or equivalent mid dose capsule |
|
| HTL0018318 high dose | Active Comparator | high dose aqueous solution and/or equivalent high dose capsule(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTL0018318 | Drug | Two single doses of active drug (low, mid or high dose either as aqueous solution or capsule) separated by a washout of at least 12 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of HTL0018318 | Comparison of bioavailability in plasma | Predose to 168h post dose |
| Area under the curve (AUC) of HTL0018318 | Comparison of bioavailability in plasma | Predose to 168h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (tmax) | Pharmacokinetics in plasma | Predose to 168h post dose |
| Half-life (t1/2) | Pharmacokinetics in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeep Puri, MPhil MBBS | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
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| Predose to 168h post dose |
| Apparent volume of distribution (Vz/F) | Pharmacokinetics in plasma | Predose to 168h post dose |
| Apparent clearance (CLp/F) | Pharmacokinetics in plasma | Predose to 168h post dose |
| Amount excreted in urine (Ae) | Pharmacokinetics in urine | Predose to 168h post dose |
| Fraction excreted in urine (fe/F) | Pharmacokinetics in urine | Predose to 168h post dose |
| Clearance in urine (CLr) | Pharmacokinetics in urine | Predose to 168h post dose |
| Treatment-emergent adverse events | Adverse events | Predose up to 28 days post dose |
| Vital signs | Heart rate and blood pressure | Predose up to 28 days post dose |
| Physical examinations | Physical examinations | Predose up to 28 days post dose |
| Laboratory safety assessments | Hematology | Predose up to 28 days post dose |
| ECG | ECG | Predose up to 28 days post dose |