A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants

Study Overview
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Brief Summary
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The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.

Official Title
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A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Danicopan Modified Release Prototype 1
* Drug: Danicopan Modified Release Prototype 2
* Drug: Danicopan Modified Release Prototype 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index of 18.0 to 30.0 kilograms/square meter. Female participants of childbearing potential must either agree to abstinence or use of a highly effective method of contraception. Male participants must either agree to abstinence or use of a condom plus an effective method of contraception. Exclusion Criteria: Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months. History of any drug or alcohol abuse in the past 2 years; current tobacco/nicotine user or within the last 12 months; positive drugs of abuse test result. Clinically significant laboratory abnormalities. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder. History or family history of meningococcal infection. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients. Presence or history of clinically significant allergy requiring treatment. Donation or loss of greater than 400 milliliters of blood within the previous 3 months. Note: Other inclusion/exclusion criteria may apply, per protocol.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danicopan Modified Release Prototype Tablets<br>Participants received danicopan once each period as a single oral dose as follows: Period 1: Danicopan Modified Release Prototype 1 under fasted conditions. Period 2: Danicopan Modified Release Prototype 2 under fasted conditions. Period 3: Danicopan Modified Release Prototype 3 under fasted conditions. Period 4: Danicopan Modified Release Prototype 2 under fed conditions. There was a washout period of at least 14 days between each danicopan dosing. | Drug: Danicopan Modified Release Prototype 1<br>* Danicopan (400 milligrams [mg]) oral tablet.<br>* Other names: 4471;Drug: Danicopan Modified Release Prototype 2<br>* Danicopan (400 mg) oral tablet.<br>* Other names: 4471;Drug: Danicopan Modified Release Prototype 3<br>* Danicopan (800 mg) oral tablet.<br>* Other names: 4471;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation |  | Up to 72 hours postdose | 
| Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation |  | Up to 72 hours postdose | 
| Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation |  | Up to 72 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Experiencing Treatment-emergent Adverse Events |  | Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Modified Release, Factor D Inhibitor, Relative Bioavailability, Danicopan, ALXN2040, ACH-0144471