Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04889391




Registration number
NCT04889391
Ethics application status
Date submitted
12/05/2021
Date registered
17/05/2021
Date last updated
17/05/2021

Titles & IDs
Public title
Study of Radiolabeled Danicopan in Healthy Male Participants
Scientific title
A Phase I, Open-Label, Single Dose ADME Study of 14C-ACH-0144471 in Healthy Male Subjects
Secondary ID [1] 0 0
ACH471-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - [14C]-Danicopan

Experimental: [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.


Treatment: Drugs: [14C]-Danicopan
Liquid-filled capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan
Timepoint [1] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary outcome [4] 0 0
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)
Timepoint [4] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary outcome [5] 0 0
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax)
Timepoint [5] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Primary outcome [6] 0 0
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t
Timepoint [6] 0 0
Up to 96 hours postdose
Primary outcome [7] 0 0
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf
Timepoint [7] 0 0
Up to 96 hours postdose
Primary outcome [8] 0 0
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax
Timepoint [8] 0 0
Up to 96 hours postdose
Primary outcome [9] 0 0
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax
Timepoint [9] 0 0
Up to 96 hours postdose
Primary outcome [10] 0 0
[14C]-Danicopan Metabolites In Plasma, Urine, And Feces
Timepoint [10] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Secondary outcome [1] 0 0
Percentage Of Total Radioactivity Detected For Each [14C]-Danicopan Metabolite in Plasma, Urine, And Feces
Timepoint [1] 0 0
Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Secondary outcome [2] 0 0
Incidence Of Treatment-emergent Adverse Events
Timepoint [2] 0 0
Day 1 through Day 10

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/10/2017
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Achillion, a wholly owned subsidiary of Alexion
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04889391