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| Name | Class |
|---|---|
| Hammersmith Medicines Research | OTHER |
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This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.
Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .
Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | Itraconazole DDI |
|
| Cohort B | Other | Rifampicin DDI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole oral solution | Drug | 200 mg once daily on Days 6 to 15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax) for olorofim. | 16 days | |
| Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim. | 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) of olorofim | 16 days | |
| area under the concentration-time curve to infinity (AUC0-∞) for olorofim | 16 days | |
| terminal elimination half-life (t½) for olorofim |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeep Puri | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008658 | Derived | Cornelissen K, Rex JH, Zinzi D, Law D, Upcott Gill R, Jones HM, Maertens J, Chen SC-A, Bruggemann R. Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0174525. doi: 10.1128/aac.01745-25. Epub 2026 Apr 20. |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| C000626907 | olorofim |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampicin Oral Capsule |
| Drug |
600 mg once daily on Days 6 to 15 |
|
| Olorofim | Drug | Single oral dose on Days 1 and 11 |
|
|
| 16 days |
| Number of subjects with treatment-related adverse events | 23 days |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |