Healthy
Conditions
Keywords
Danicopan, ALXN2040, ACH-0144471, Factor D Inhibitor, Pharmacokinetics, Pharmacodynamics, Ascending Dose
Brief summary
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.
Interventions
DRUGDanicopan
DRUGPlacebo
Sponsors
Achillion, a wholly owned subsidiary of Alexion
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests. * Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
Exclusion criteria
* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * Any condition possibly affecting drug absorption (for example, gastrectomy), cholecystectomy to be considered acceptable. * Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration. * Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of Screening; positive urine drug screen at Screening or Day -1. * Clinically significant laboratory abnormalities at either Screening or Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities | Day 1 through Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Time To Reach The Maximal Plasma Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 hours postdose |
| Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 hours postdose |
| Maximal Plasma Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions | Up to 144 hours postdose |
| Relationship Between Alternative Pathway Inhibition And Danicopan Plasma Concentrations | Up to 144 hours postdose |
Countries
New Zealand
Outcome results
None listed