Status:
COMPLETED
Study of Radiolabeled Danicopan in Healthy Male Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04889391
Start Date
September 14 2017
End Date
October 15 2017
Last Update
May 17 2021
Active Locations (1)
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1
Clinical Trial Site
Auckland, New Zealand