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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/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
Basic Science
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
This was a randomized, crossover, open-label study to assess the relative bioavailability,
pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet,
softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04940559
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