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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002604-87 | EudraCT Number |
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The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1 | Experimental | Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of [14C-pos 1]-Debio 1450 BES solution. |
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| Part A: Cohort 2 | Experimental | Participants receive a single oral dose of 240 mg/3.7 MBq of [14C-pos 1]-Debio 1450 BES solution. |
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| Part B: Cohort 3 | Experimental | Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of [14C-pos 25]-Debio 1450 BES solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C-pos 1]-Debio 1450 BES Solution | Drug | A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery after a single dose of radiolabelled Debio 1450 measured through total radioactivity excreted in expired air, urine and faeces | 168 hours after dosing (Day 8) | |
| Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes | 168 hours after dosing (Day 8) | |
| Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood | Blood is collected within the 168 hours as follows:
| 168 hours after dosing (Day 8) |
| Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters | 168 hours after dosing (Day 8) |
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Inclusion Criteria:
Exclusion Criteria:
Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Annick Ménétrey | Debiopharm International, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd. | Leeds | LS2 9LH | United Kingdom |
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| [14C-pos 25]-Debio 1450 BES Solution | Drug | A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25 |
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