Study of Radiolabeled Danicopan in Healthy Male Participants

Study Identifier:
ACH471-005
ClinicalTrials.gov Identifier:
NCT04889391
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: [14C]-Danicopan
Date
Sep 2017 - Oct 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
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.
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.
Sex
Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: [14C]-Danicopan
Date
Sep 2017 - Oct 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
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.
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.

Protocol 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 \[14C\].

Trial Locations

Location
Status
Location
Clinical Trial Site
Auckland, New Zealand
Status
N/A