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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Danicopan Modified Release Prototype 1; Drug: Danicopan Modified Release Prototype 2; Drug: Danicopan Modified Release Prototype 3

• Registration Number: NCT03384186
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-23
• Study First Posted: 2017-12-27
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Danicopan Modified Release Prototype Tablets	Danicopan Modified Release Prototype 1	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.
Danicopan Modified Release Prototype Tablets	Danicopan Modified Release Prototype 2	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.
Danicopan Modified Release Prototype Tablets	Danicopan Modified Release Prototype 3	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Clinical Trial Site; 🇬🇧 Ruddington, Nottingham, United Kingdom