Study of Radiolabeled Danicopan in Healthy Male Participants

Healthy Clinical Trial

Official title:

A Phase I, Open-Label, Single Dose ADME Study of 14C-ACH-0144471 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889391
• Other study ID #: ACH471-005
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2017
• Est. completion date: October 15, 2017

Study information

• Verified date: May 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 15, 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-Danicopan
Liquid-filled capsules.

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary	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)		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary	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)		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary	Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary	Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax)		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary	Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t		Up to 96 hours postdose
Primary	Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf		Up to 96 hours postdose
Primary	Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax		Up to 96 hours postdose
Primary	Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax		Up to 96 hours postdose
Primary	[14C]-Danicopan Metabolites In Plasma, Urine, And Feces		Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Secondary	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.	Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Secondary	Incidence Of Treatment-emergent Adverse Events		Day 1 through Day 10