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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as intact tablets and via NG tube
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV | Other | 2 h IV infusion (Groups A/B) |
|
| oral (fasted) | Other | 30 mg tablets given after an overnight fast (Groups A/B) |
|
| oral (fed) | Other | 30 mg tablets given after a high fat breakfast (Groups A/B) |
|
| oral (intact tablet) | Other | 30 mg tablets (Group C) |
|
| oral (NG tube) | Other | 30 mg tablets in water via NG tube (Group C) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olorofim | Drug | 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax) for olorofim | 35 days | |
| area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim | 35 days | |
| Absolute bioavailability of olorofim (F) | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (TMax) for olorofim | 35 days | |
| area under the concentration time curve to infinity (AUC0-∞) for olorofim | 35 days | |
| terminal elimination half-life (t½) for olorofim |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MBChB | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | West Yorkshire | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C000626907 | olorofim |
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3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C
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| 35 days |
| Number of subjects with treatment-related adverse events | 35 days |