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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg [14C]-acebilustat | Other | a single oral dose of 100 mg [14C]-acebilustat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-acebilustat solution | Drug | Acebilustat is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity in all excreta: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the administered dose (Cum%Ae) | Day 10 |
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Inclusion Criteria:
• Body mass index of 18.0 to 35.0 kg/m2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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