A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
| Registry | NCT03108274 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, basic science |
| Enrollment | 35 (Actual) |
| Sponsor | Alexion Pharmaceuticals, Inc. (Industry); collaborators: Achillion, a wholly owned subsidiary of Alexion |
| Conditions | Healthy |
| Interventions | Danicopan, Midazolam, Fexofenadine, Mycophenolate Mofetil (Drug) |
| Dates | start 2017-04-18, primary completion 2017-06-02, completion 2017-06-16, first posted 2017-04-11, last updated 2021-06-24 |
| Locations | 1 site in New Zealand |
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The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult participants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Part 1: Danicopan and Midazolam | Experimental | Drug: Danicopan; Drug: Midazolam | Period 1: Participants received a single dose of midazolam. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam. Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
| Part 2: Danicopan and Fexofenadine | Experimental | Drug: Danicopan; Drug: Fexofenadine | Period 1: Participants received a single dose of fexofenadine. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine. Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
| Part 3: Danicopan and MMF | Experimental | Drug: Danicopan; Drug: Mycophenolate Mofetil | Period 1: Participants received a single dose of MMF. Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF. Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Key Inclusion Criteria: * Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests. * Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg. Key Exclusion Criteria: * Mentally or legally incapacitated or significant emotional problems. * Any condition that might interfere with drug absorption. * History of sensitivity to study medication or other drug allergies. * Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose. * Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration. * Participated in another clinical study within 28 days prior to the first dose. * Significant laboratory abnormalities. * Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.
| Facility | City | Country | Status |
|---|---|---|---|
| Clinical Trial Site | Auckland | New Zealand |