CompletedNCT04889391Updated May 17, 2021

Study of Radiolabeled Danicopan in Healthy Male Participants

A Phase 1 interventional study of [14C]-Danicopan in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in New Zealand. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-17.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Oct 2017, 8 years 11 months ago, and no results have been posted to the registry.
Registered 3 years 7 months after the study started (first participant enrolled Sep 2017, registered May 2021).

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years to 55 Years
Sex: Male

Study 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].

Conditions studied

Healthy

Keywords

Danicopan
ACH-0144471
ALXN2040
Absorption
Distribution
Metabolism
Excretion
Total Radioactivity
ADME

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
[14C]-Danicopan
Participants were administered a single oral dose of danicopan between 151 and 154 mg (nominal dose of 150 mg), providing approximately 100 μCi of \[14C\] radiolabel in the form of \[14C\]-danicopan.
Drug: [14C]-Danicopan

Interventions

Drug[14C]-Danicopan
Liquid-filled capsules.
Also known as: ALXN2040, ACH-014447, ACH-4471, ACH4471, 4471

What researchers measure

Primary outcomes

Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
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)
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
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)
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax)
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t
Time frame: Up to 96 hours postdose
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf
Time frame: Up to 96 hours postdose
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax
Time frame: Up to 96 hours postdose
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax
Time frame: Up to 96 hours postdose
[14C]-Danicopan Metabolites In Plasma, Urine, And Feces
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period

Secondary outcomes

Percentage Of Total Radioactivity Detected For Each [14C]-Danicopan Metabolite in Plasma, Urine, And Feces
\[14C\]-Danicopan metabolic profiling in plasma, urine, and feces was performed in samples containing sufficient amounts of radioactivity. The percent of dose represented by each of the metabolites was calculated using the radioactivity concentration equivalent data combined with the metabolic profiling data. The percentage of each identified metabolite to total radioactivity in plasma was estimated based on plasma metabolic profiling data.
Time frame: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Incidence Of Treatment-emergent Adverse Events
Time frame: Day 1 through Day 10

Study locations

1 site

Clinical Trial Site
Auckland, New Zealand

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04889391
Lead sponsor: Alexion Pharmaceuticals, Inc.
Collaborators: Achillion, a wholly owned subsidiary of Alexion
Responsible party: Sponsor
First posted: May 17, 2021
Start date: Sep 14, 2017
Primary completion: Oct 15, 2017
Completion: Oct 15, 2017
Last update: May 17, 2021

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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