Skip to main content
OpenTrials
Completed

NCT Number: NCT04940559

Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 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.

Key Inclusion Criteria:

  • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
  • Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.

Key Exclusion Criteria:

  • History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • History of procedures that could alter absorption of orally administered drugs.
  • Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
  • Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
  • Participation in a clinical study within 30 days prior to study drug administration.
  • Clinically significant laboratory abnormalities at Screening or Day -1.

Treatment and study plan

Danicopan - Tablet

Drug

Oral tablet.

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

Danicopan - Softgel

Drug

Oral softgel capsule.

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

Danicopan - LFC

Drug

Oral LFC.

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

Primary outcomes

  1. PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations

    Time frame: Up to 96 hours postdose

  2. PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations

    Time frame: Up to 96 hours postdose

  3. PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations

    Time frame: Up to 96 hours postdose

Secondary outcomes

  1. PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions

    Time frame: Up to 96 hours postdose

  2. PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions

    Time frame: Up to 96 hours postdose

  3. PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions

    Time frame: Up to 96 hours postdose

  4. Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation

    Time frame: Day 1 through Day 39

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 Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2021
Registry last updated
Jun 25, 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.

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