11 completed, 5 withdrawn. 16 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 16 | Completed 11, Withdrawn 5 |
| Phase 2 | 2 | Withdrawn 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim Olorofim - Healthy | Phase 1 | Completed | F2G Ltd | 24 | 2019-12-05 | 2021-01-08 |
| Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim Itraconazole oral solution, Rifampicin Oral Capsule, Olorofim - Healthy | Phase 1 | Completed | F2G Ltd | 24 | 2019-11-18 | 2020-07-24 |
| Absorption, Metabolism and Excretion of 14C-olorofim in Man Olorofim - Invasive Fungal Infections | Phase 1 | Completed | F2G Ltd | 12 | 2019-07-30 | 2019-11-13 |
| Radiolabelled IV and Oral Metabolism Study of F901318 IV F901318, Oral F901318 - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2019-05-01 | 2019-07-26 | |
| Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects F901318 - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 45 | 2017-12-12 | 2018-08-02 |
| Pharmacokinetics of IV Formulation F901318 - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2017-05-01 | 2017-11-01 | |
| Drug/Drug Interactions With F901318 cyclosporine A, Posaconazole, Pantoprazole - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2017-05-01 | 2017-11-01 | |
| Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients F901318, Caspofungin - Pulmonary Aspergillosis - Invasive, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | F2G Ltd | 2017-04-20 | 2018-02-15 | |
| Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia F901318 with fluconazole low dose, F901318 with fluconazole high dose, F901318 with posaconazole - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | F2G Ltd | 2017-03-01 | 2018-02-15 | |
| Evaluation of Immediate Release Tablet F901318 SDD, F901318 IR, F901318 IR Fasting - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 20 | 2016-07-01 | 2016-11-28 |
| Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects F901318 Dose level A oral, Placebo dose level A oral, F901318 Dose level B oral - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 40 | 2016-05-01 | 2017-05-23 |
| Study of Potential for Interaction of Fluconazole With F901318 F901318, Fluconazole - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 20 | 2016-02-01 | 2017-02-02 |
| Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe Midazolam with F901318 - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 20 | 2016-01-01 | 2016-06-09 |
| Single Ascending Oral Dose Study of F901318 F901318 safety, F901318 tolerability, F901318 pharmacokinetics - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 46 | 2015-10-01 | 2016-09-19 |
| F901318 Multiple Ascending Dose Study F901318, Placebo - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 72 | 2015-02-01 | 2016-09-19 |
| F901318 Single Ascending Dose Study in Healthy Male Volunteers F901318, Placebo - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 40 | 2014-08-01 | 2015-09-07 |
Leukemia, Myeloid, Acute (2) · Invasive Fungal Infections (1) · Invasive Pulmonary Aspergillosis (1)
olorofim (13) · Antifungal Agents (2) · Fluconazole (2) · posaconazole (2) · Caspofungin (1) · Cyclosporine (1) · Itraconazole (1) · Metabolism (1) · Midazolam (1) · Pantoprazole (1) · Rifampin (1) · Tacrolimus (1)
United Kingdom (11) · Netherlands (1)
Girish Sharma (2) · A Stewart (1) · Adeep Puri (1) · David Bell, MD (1) · Frans van den Berg, MB ChB (1) · Jan Jaap van Lier, MD (1) · Jim Bush, MB ChB PhD MRCS FFPM (1) · Jim Bush, MBChB (1) · Litza McKenzie, MD (1) · Oliver A Cornely, MD (1) · Oliver Cornely, PhD, MD (1) · Salvatore Febbraro, MD (1)
2014 (1)