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OpenTrials
Completed

NCT Number: NCT04889690

Study of Multiple Doses of Danicopan in Healthy Participants

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.

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Danicopan

Drug

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

Placebo

Drug

Primary outcomes

  1. Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities

    Time frame: Day 1 through Day 42

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) Of Danicopan

    Time frame: Up to 16 hours postdose

  2. Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan

    Time frame: Up to 16 hours postdose

  3. Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan

    Time frame: Up to 16 hours postdose

  4. Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay

    Time frame: Up to 16 hours postdose

  5. Relationship Between AP Inhibition And Danicopan Plasma Concentrations

    Time frame: Up to 16 hours postdose

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

A Multiple Ascending Dose Study To Assess Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ACH-0144471 In Healthy Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2021
Registry last updated
May 17, 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.

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