Clinical trial NCT04889391: Study of Radiolabeled Danicopan in Healthy Male Participants
Official title: A Phase I, Open-Label, Single Dose ADME Study of 14C-ACH-0144471 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Danicopan
ACH-0144471
ALXN2040
Absorption
Distribution
Metabolism
Excretion
Total Radioactivity
ADME
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2021-05-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 (\[14C\])-ACH-014447 (\[14C\])-danicopan) containing approximately 100 microcuries (µCi) of \[14C\].


Eligibility criteria: Key Inclusion Criteria:

* Healthy was defined as having no clinical relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of ≥ 18 and ≤ 30 kilograms (kg)/meter squared and weight of ≥ 50 kg and ≤ 100 kg.
* Regular daily bowel movements (that is, production of at least 1 stool per day).
* Non-smoker or ex-smoker who had not used tobacco or nicotine products for ≥ 3 months prior to screening.

Key Exclusion Criteria:

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History of conditions or procedures possibly affecting drug absorption or excretion. A history of appendectomy, cholecystectomy, and hernia repair was allowed if they were not associated with complications.
* Active bacterial infection or clinically significant active viral infection, a body temperature \> 38°Celcius, or other evidence of infection on Day 1, or with a history of febrile illness within 7 days prior to Day 1.
* Healthy participants who had been exposed to significant radiation levels of \> 5 millisieverts in the last year prior to screening.
* Clinically significant laboratory abnormalities at screening or Day -1, as well as absolute neutrophil counts, platelets, and hemoglobin outside of reference ranges.

Primary outcomes:
measure: Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Whole Blood And Plasma Pharmacokinetics (PK) Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve From Time 0 To The Time Of Last Quantifiable Concentration (AUC0-t)
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve Extrapolated to Infinity (AUC0-inf)
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax)
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t
timeFrame: Up to 96 hours postdose
measure: Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf
timeFrame: Up to 96 hours postdose
measure: Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax
timeFrame: Up to 96 hours postdose
measure: Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax
timeFrame: Up to 96 hours postdose
measure: [14C]-Danicopan Metabolites In Plasma, Urine, And Feces
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Secondary outcomes:
measure: Percentage Of Total Radioactivity Detected For Each [14C]-Danicopan Metabolite in Plasma, Urine, And Feces
timeFrame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
measure: Incidence Of Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 10
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Trial Site
Study officials:
References: