Skip to main content
OpenTrials
Completed

NCT Number: NCT03384186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Ruddington, Nottingham, NG111 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Danicopan Modified Release Prototype 1

Drug

Danicopan (400 milligrams [mg]) oral tablet.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Danicopan Modified Release Prototype 2

Drug

Danicopan (400 mg) oral tablet.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Danicopan Modified Release Prototype 3

Drug

Danicopan (800 mg) oral tablet.

Other names: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Primary outcomes

  1. Time To Maximum Observed Concentration (Tmax) Of Danicopan After Treatment With Each Prototype Formulation

    Time frame: Up to 72 hours postdose

  2. Maximum Observed Concentration (Cmax) Of Danicopan After Treatment With Each Prototype Formulation

    Time frame: Up to 72 hours postdose

  3. Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan After Treatment With Each Prototype Formulation

    Time frame: Up to 72 hours postdose

Secondary outcomes

  1. Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up visit (10 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2017
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.