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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03384186

Enrollment

Registered

2017-12-27

Start date

2017-12-01

Completion date

2018-03-21

Last updated

2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Danicopan, ALXN2040, ACH-0144471, Pharmacokinetics, Modified Release, Factor D Inhibitor, Relative Bioavailability

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.

Interventions

DRUGDanicopan Modified Release Prototype 1

Danicopan (400 milligrams \[mg\]) oral tablet.

DRUGDanicopan Modified Release Prototype 2

Danicopan (400 mg) oral tablet.

DRUGDanicopan Modified Release Prototype 3

Danicopan (800 mg) oral tablet.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026