Study of Radiolabeled Danicopan in Healthy Male Participants

Alexion Pharmaceuticals, Inc.8 enrolled

Overview

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 \[14C\].

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]-DanicopanDRUG

Liquid-filled capsules.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Site

Auckland, New Zealand

Outcomes

Primary Outcomes

Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan