Study of Radiolabeled Danicopan in Healthy Male Participants

NCT ID: NCT04889391

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2017-10-15

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].

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[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.

Group Type: EXPERIMENTAL

[14C]-Danicopan

Intervention Type: DRUG

Liquid-filled capsules.

Interventions

[14C]-Danicopan

Liquid-filled capsules.

Intervention Type: DRUG

Other Intervention Names

ALXN2040; ACH-014447; ACH-4471; ACH4471; 4471

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

ACH471-005

Identifier Type: -

Identifier Source: org_study_id