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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Danicopan Modified Release Prototype 1; Drug: Danicopan Modified Release Prototype 2; Drug: Danicopan Modified Release Prototype 3

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG111 6JS
      • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Danicopan Modified Release Prototype Tablets; 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; Danicopan (400 milligrams [mg]) oral tablet.; Other Names: ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; Drug: Danicopan Modified Release Prototype 2; Danicopan (400 mg) oral tablet.; Other Names: ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; Drug: Danicopan Modified Release Prototype 3; Danicopan (800 mg) oral tablet.; Other Names: ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals
• Collaborators: Achillion, a wholly owned subsidiary of Alexion

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): March 21, 2018
• Study Completion (ACTUAL): March 21, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 23, 2017
• First Posted (ACTUAL): December 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Danicopan; ALXN2040; ACH-0144471; Factor D Inhibitor; Relative Bioavailability; Modified Release
• Other Study ID Numbers: ACH471-011; 2017-003525-15 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes