Study of a Single Dose of Danicopan in Healthy Participants

Study Identifier:
ACH471-001
ClinicalTrials.gov Identifier:
NCT04889677
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
Feb 2016 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 21 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria:
  • Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse 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 (for example, gastrectomy), cholecystectomy to be considered acceptable.
  • Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
  • Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or 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
21 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: Danicopan
  • Drug: Placebo
Date
Feb 2016 - Jun 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 21 - 55 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Inclusion Criteria:
  • Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse 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 (for example, gastrectomy), cholecystectomy to be considered acceptable.
  • Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
  • Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or 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 single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.

Trial Locations

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