Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Danicopan - Tablet
* Drug: Danicopan - Softgel
* Drug: Danicopan - LFC


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Sequence 1<br>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. | Drug: Danicopan - Tablet<br>* Oral tablet.<br>* Other names: 4471;Drug: Danicopan - LFC<br>* Oral LFC.<br>* Other names: 4471;|
| Experimental: Group 1: Sequence 2<br>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. | Drug: Danicopan - Tablet<br>* Oral tablet.<br>* Other names: 4471;Drug: Danicopan - LFC<br>* Oral LFC.<br>* Other names: 4471;|
| Experimental: Group 1: Sequence 3<br>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. | Drug: Danicopan - Tablet<br>* Oral tablet.<br>* Other names: 4471;Drug: Danicopan - LFC<br>* Oral LFC.<br>* Other names: 4471;|
| Experimental: Group 2: Sequence 1<br>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. | Drug: Danicopan - Softgel<br>* Oral softgel capsule.<br>* Other names: 4471;Drug: Danicopan - LFC<br>* Oral LFC.<br>* Other names: 4471;|
| Experimental: Group 2: Sequence 2<br>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. | Drug: Danicopan - Softgel<br>* Oral softgel capsule.<br>* Other names: 4471;Drug: Danicopan - LFC<br>* Oral LFC.<br>* Other names: 4471;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations |  | Up to 96 hours postdose | 
| PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations |  | Up to 96 hours postdose | 
| PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations |  | Up to 96 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions |  | Up to 96 hours postdose | 
| PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions |  | Up to 96 hours postdose | 
| PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions |  | Up to 96 hours postdose | 
| Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation |  | Day 1 through Day 39 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Danicopan, ALXN2040, ACH-0144471, Relative Bioavailability, LFC, Tablet, Softgel Capsule, Food Effect, Pharmacokinetics, Factor D Inhibitor, Safety