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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Basic Science
Allocation to intervention
N/A
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
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].
Trial website
https://clinicaltrials.gov/ct2/show/NCT04889391
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