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

Study Identifier:
ACH471-011
ClinicalTrials.gov Identifier:
NCT03384186
EudraCT Identifier:
2017-003525-15
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan Modified Release Prototype 1
  • Drug: Danicopan Modified Release Prototype 2
  • Drug: Danicopan Modified Release Prototype 3
Date
Dec 2017 - Mar 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
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.
Sex
Female & Male
Age
18 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan Modified Release Prototype 1
  • Drug: Danicopan Modified Release Prototype 2
  • Drug: Danicopan Modified Release Prototype 3
Date
Dec 2017 - Mar 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
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.

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Ruddington, Nottingham, United Kingdom, NG111 6JS
Status
N/A