Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Itraconazole 200mg | Active Comparator |
| |
| Part 2: Phenytoin 100mg | Active Comparator |
| |
| Part 3: Simvastatin 40mg | Active Comparator |
| |
| Part 4: Upadacitinib 15 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leramistat 40mg | Drug | Oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| leramistat: Area under the curve - AUC0-t | 8.5 Weeks | |
| leramistat: Area under the curve - AUC0-24h | 8.5 Weeks | |
| leramistat: Area under the curve - AUC0-inf | 8.5 weeks | |
| leramistat: Maximum observed concentration - Cmax | 8.5 weeks | |
| leramistat: Time of the maximum observed concentration - Tmax | 8.5 weeks | |
| leramistat:Elimination rate constant -Kel | 8.5 weeks | |
| leramistat: Half life - t½ | 8.5 weeks | |
| leramistat: Plasma Clearance -CL/F | 8.5 weeks | |
| leramistat: Volume of distribution - Vz/F | 8.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event. | 8.5 weeks |
Not provided
Principal Inclusion Criteria:
Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.
Principal Exclusion Criteria:
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | +44 (0)207 444 0066 | ist05@istesso.co.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Recruiting | Belfast | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D010672 | Phenytoin |
| D019821 | Simvastatin |
| C000613732 | upadacitinib |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Itraconazole 200 mg | Drug | Oral capsule |
|
| Phenytoin 100 Mg Oral Capsule | Drug | Oral capsule |
|
| Simvastatin 40mg | Drug | Oral capsule |
|
| Upadacitinib 15 MG | Drug | Oral Capsule |
|
| D010879 |
| Piperazines |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |