Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT04940559




Registration number
NCT04940559
Ethics application status
Date submitted
21/06/2021
Date registered
25/06/2021
Date last updated
25/06/2021

Titles & IDs
Public title
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
Scientific title
A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers
Secondary ID [1] 0 0
ACTRN12616001017415
Secondary ID [2] 0 0
ACH471-006
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 - Danicopan - Tablet
Treatment: Drugs - Danicopan - Softgel
Treatment: Drugs - Danicopan - LFC

Experimental: Group 1: Sequence 1 - Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.

Experimental: Group 1: Sequence 2 - Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.

Experimental: Group 1: Sequence 3 - Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.

Experimental: Group 2: Sequence 1 - Participants received danicopan once each period as a single dose under fasted conditions as follows:

Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.

Experimental: Group 2: Sequence 2 - Participants received danicopan once each period as a single dose under fasted conditions as follows:

Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.


Treatment: Drugs: Danicopan - Tablet
Oral tablet.

Treatment: Drugs: Danicopan - Softgel
Oral softgel capsule.

Treatment: Drugs: Danicopan - LFC
Oral LFC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
Timepoint [1] 0 0
Up to 96 hours postdose
Primary outcome [2] 0 0
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
Timepoint [2] 0 0
Up to 96 hours postdose
Primary outcome [3] 0 0
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
Timepoint [3] 0 0
Up to 96 hours postdose
Secondary outcome [1] 0 0
PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Timepoint [1] 0 0
Up to 96 hours postdose
Secondary outcome [2] 0 0
PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Timepoint [2] 0 0
Up to 96 hours postdose
Secondary outcome [3] 0 0
PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Timepoint [3] 0 0
Up to 96 hours postdose
Secondary outcome [4] 0 0
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation
Timepoint [4] 0 0
Day 1 through Day 39

Eligibility
Key inclusion criteria
Key

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
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 procedures that could alter absorption of orally administered drugs.
* Body temperature = 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
* Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
* Participation in a clinical study within 30 days prior to study drug administration.
* Clinically significant laboratory abnormalities at Screening or Day -1.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
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
Crossover
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
2/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2016
Sample size
Target
Accrual to date
Final
26
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/NCT04940559