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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Danicopan Modified Release Prototype 3; Drug: Danicopan Modified Release Prototype 1; Drug: Danicopan Modified Release Prototype 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03384186

2017-003525-15 (EudraCT Number)

ACH471-011

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Danicopan Modified Release Prototype Tablets

Experimental group

Description:

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.

Treatment:

Drug: Danicopan Modified Release Prototype 2

Drug: Danicopan Modified Release Prototype 3

Drug: Danicopan Modified Release Prototype 1