Study of Multiple Doses of Danicopan in Healthy Participants

Study Identifier:
ACH471-002
ClinicalTrials.gov Identifier:
NCT04889690
EudraCT Identifier:
N/A
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
  • Drug: Placebo
Date
May 2016 - Jan 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 25 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
  • Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
Exclusion Criteria
  • History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Any condition possibly affecting drug absorption (including gastrectomy and cholecystectomy).
  • Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.
  • Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening; positive urine drug screen at screening or Day -1.
  • Clinically significant laboratory abnormalities at either Screening or Day -1.
Sex
Female & Male
Age
25 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan
  • Drug: Placebo
Date
May 2016 - Jan 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 25 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
  • Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
Exclusion Criteria
  • History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Any condition possibly affecting drug absorption (including gastrectomy and cholecystectomy).
  • Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.
  • Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening; positive urine drug screen at screening or Day -1.
  • Clinically significant laboratory abnormalities at either Screening or Day -1.

Protocol Summary

This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams \[mg\], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.

Trial Locations

Location
Status
Location
Clinical Trial Site
Auckland, New Zealand
Status
N/A